CRM Part 1 Flashcards

1
Q

Central ca regys are the connection between what?

A

Those collecting data on pts and national ca programs

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2
Q

Central regy consolidates reports on same pt and primary cancers for all __, __, and __ items.

A

demographic, dx, and treatment

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3
Q

Consolidation of data occures at the __ and __ level, so that there is only one best record of each possible value

A

individual and record

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4
Q

Consolidation can be used to determine the best possible ___ of cancer within a ____

A

incidence / defined geographic area

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5
Q

Central regy data is aggregated at these levels

A

national and international

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6
Q

Many central regys are located in

A

state health depts

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7
Q

Central regys are governed by (x2)

A

laws of state / standards and requirements of federal funding agencies

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8
Q

All central regys are funded by __, ___ or both

A

CDC’s NPCR / NCI SEER

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9
Q

Staffing for central regy depends on (x3)

A
  1. goals of regy 2. caseload 3. nature of data collection process
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10
Q

What is FTE for essential central regy function

A

12.4

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11
Q

Other professionals employed in central regy (x6)

A

Epidemiologists, statisticians, informaticists, IT and admin support personel and manager or director overseeing BUDGET and PROGRAMATIC PLANNING

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12
Q

Majority of central regy data comes from

A

hospitals

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13
Q

Why is receiving data from different type of reporting sources important

A

fills gaps in patient and tumor record

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14
Q

Central regy - all cases for a diagnosis year must be submitted to the central regy no later than…

A

6 months after dx

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15
Q

RCA is

A

rapdid case ascertainment

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16
Q

Hosital reg maintain data on all patients ___ and report all cases to the central reg after ___, ___, and ___ are completed at the hospital level

A

treated for ca at their facility
casefinding, abstracting, and editing are completed

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17
Q

When hospitals submit their data to the state’s central reg it uses a STANDARDIZED FORMAT. What is the format?

A

NAACCRs data exchange record layout

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18
Q

Name other health-care reporting sources.

Note that they are generally required by STATE STATUTES to report cancer dx and/or tx to their respectiver registries

A

outpt cancer centers
path labs
med onc facilities
surgery centers
imaging and radiology centers

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19
Q

Ca dxs that are often dx outside of hospital setting include (5)

A

prostate
urinary
heme (MDS)
urology
dermatology

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20
Q

Path reports are a critical data source for central regy. What percentage of cases reported to U.S. central regy were dx using path reports

A

94%

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21
Q

Many states have developed ____ which collects claims data from ____ for inpt tx, outpt tx, and pharmacy claims

A

APCD - all payer claims database
health insurance companies

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22
Q

With APCD data can be pulled from claim information through what kind of linkage

A

probablistic

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23
Q

What is the interstate data exchange?

A

Most central reg have data sharing agreements with other states to match data obtained from out-of-state data exchanges with facilities (other ca reg, state depts of health, path labs)

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24
Q

What is signed between different state’s central regys

A

NAACCRs National Interstate Data Exchange Agreement

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25
Who typically does casefinding?
Hospital regys, central regys depend on them but the central regy may perform casefinding on NONHOSPITAL facilities
26
What nonhospital sources do central regys use?
path reports from freestanding labs and derm offices disease indices from outpt centers disease indices from hospice or nursing homes death certificate files
27
Consolidations must occur for data on same pt and tumor. Multiple reports from sources are called
source records
28
What is CCRDB
central ca regy database
29
When consolidating, central regys often use 4 components to ensure data is accurate and each new cancer is counted only once. What are they?
data edits patient record linkage tumor record linkage data item consolidation
30
What happens when central regy source records are subjected to electronic data edits for completeness and and inncuacies or errors are found?
Sent back to reporting facility or corrected and resubmiited for editing by central reg staff
31
When no errors are found in source records at the central regy, what is the next step?
patient record linkage
32
What is the patient record?
the individual person with one or more primary cancers/reportable neoplasms
33
What data items are included in the patient record?
name dob SSN race etc
34
Record linkage is performed to determine what?
if pt has an existing record in the CCRDB
35
List the steps in the CCRDB record linkage process (5)
1. souce record is imported 2. data edits performed to check for errors 3. if all good PT RECORD LINKAGE performed (exisitng pt vs creating new record for pt) 4. If pt is already in system TUMOR RECORD LINKAGE performed (pt record updated to add new tumor or patient record updated for original tumor)
36
What is a perfect match in record linkage?
CCRDB algorithms find a match with all key demographics (name, dob, ssn, etc)
37
What is a probably match in record linkage?
CCRDB algorithms find a match in demographics (name, dob, etc) but there is say a 1 digit difference in SSN
38
What often is the process for probable matches in record linkage?
manual review
39
Each tumor record is counted in what?
Incidence data
40
What are same data items included in a tumor record?
primary site histology stage tx info abt pt at time of dx
41
What is data item consolidation?
Central reg identify difference between info from 2+ sources for the same pt and/or tumor and determine the best data values
42
If a record is modified during the data item consolidation process, what is the record called? What happens to the original unmodified source record and what is it called?
consolidated record it is kept unmodified and called the PRISTINE record
43
If a record is modified during the data item consolidation process, what is the record called? What happens to the original unmodified source record and what is it called?
manual and automated manual is often for complex, interrelated and compound variables and automated is for simple variables
44
Why is geocoding helpful?
calculating local rates identifying areas with high or low risk - which can help identify underreporting
45
Who does geocoding?
central reg
46
Geocoding helps identify and analyze relationships between
incidence and cancer risk factors
47
Follow up os determined by VITAL STATUS, which generally falls into what 2 categories
date of last living contact reports of death
48
Name some of the linkages that provide date of last living contact
DMV Voter registration Medicare and Medicare services
49
Name some of the linkages that provide reports of death
National Death Index Social Securit Death Index
50
NCI and CDC provide central regs with guidance on requirements for follow up data. NCI funded use ___ methods while CDC requires ___
active and passive passive (through death certificate file from the the state and NCHS National Death Index
51
Death clearance is the process of matching ____ against _____
death in pop reportable conditions
52
What are the steps in death clearance?
Death clearance match (match is found) and death clearance follow-back (no match found - invesigation must be done to identify missed cases)
53
During death clearance, if no match can be found and investigation leads to nothing, this is a
DCO case - death certificate only
54
Central reg with a DCO rate (cases identified as DCO) must be below ___ to achieve NAACCR certification
5%
55
What are causes of central reg with high DCO percentages?
Incomplete reportable list 1+ newly identified facilities have not begun reporting yet Known facility failed to report all required cases
56
Central reg do not have access to this
patient medical records
57
____ and ___ collect data for the entire US
CDC and NCI
58
Standardization of data allow for ___ and ___ across geopolitical boundaries
aggregation and comparibility
59
Standards refer to the __________ and ______ by a SINGLE STANDARD SETTER
data collection and
60
Data standardization refers to these 4 things among multiple standard setters
agreement of fields field lengths codes instructions for data collection
61
Data are _____ that check the content entered in data fields against ____
software algorithms / standardized codes
62
Data edit requirement standard setts are ... (4)
SEER - primary site, morphology, grade COC - TNM NAACCR - SSDI CDC uses edits sponsored by SEER, CoC and NPCR
63
Who developed 1st coding guidelines
CoC - ACoS & NCI in 1950s, followed by SEER in 1971
64
Central reg in US confomr to what standards
NAACCR standards from the Standards for Ca Reg Volume II
65
CoC accredited facilities conform to what standards
STORE
66
What is the data exchange standard and who developed it What language is now used
NAACCR assists with electronic transfer of data bt hospital and central reg XML
67
Nonhospital source examples Their data standards are build on formats developed by who?
path lab and physician offices HL7 - Health Level 7 (develops standards for exchange of electronic health info)
68
Path labs standards are from who/what
NAACCR - Standards for Ca Regs Volume V
69
Data linkage is a task of which? hospital or central regy? and what is it?
central linking to ensure no cases has been missed
70
Data edits are checks for ____
data accuracy
71
Who develops edits
standard setters from codes and coding instructions
72
Who makes inter-record edits available? What are they?
NCI SEER and CDC Compares data recorded across records for pts with than one more for consistency in like data tiems and sequencing of tumor events
73
Who distributes edits? (x3)
SEER*Edits (from NCI SEER) NAACCR Edits Metafile CDCs GenEDITSPlus
74
Different bt sing-field edit and inter-record edit
single field - ITEM - checks one field at a time inter-record - MULTI-RECORD - compares data on more than 1 record (finds errors common to all records)
75
When does NAACCR provide a new version of the Edits Metafile
when new data dictionary is released
76
In addition to the standard metafile, NAACCR and CDC publish what annually?
call for data metafile
77
What program provides standardized process for creating and distributing an edit metafile as well as standard edits
EditWriter
78
What are the 7 components of NAACR Metafile and briefly describe
Agencies - standard setters who sponsor edits Edits - individual data checks Edit Sets - groups of edits applie to 1+ records in a processing run Fields - data elements to be edited in the metafile Layouts - grouping and organization of FIELDS from NAACCR data dictionary into a file format Messages - Error messages explaining the edits Tables - facilitates lookups and bulding list choices for multiple values
79
Sometimes cases are edited in batch mode prior to submission and a list of errors will generate with frequency counts (ie ERROR REPORT), what are these used for
QUALITY-CONTROL can identify areas of coding confusion for 1 or multiple abstractors and indicate areas for education
80
Edits can be overriden. Name 2 scenarios when this would apply
1. CTR reviews data and finds it be correct after all 2. Apparent problems in edit logic (confirmed with the software vendor and/or reported to NAACR)
81
The library of resources for abstracting are the same for what?
writing and resolving edits
82
Data quality activities: visual editing - briefly describe What are the risks?
comparing text documentation with abstract coded items to detect errors not found in computer edits bc it depends on humans (experienced CTRs) it is subjective and not all editors with identify same errors
83
Data quality activities: recoding audits - what is it?
verified coding guidelines are correctly applied by registrar
84
What kind of charts is good for recoding audit? why?
pareto ranks areas that need attention to decreasing order of occurence
85
Data quality activities: re-abstracting study - why? (x5)
assess quality of collected data est. rates of agreement bt registry data and info in source documents identifies probls with interpretation and coding of specific data develop standard guidelines and rules for abstracting ambiguous scenarios
86
Data quality activities: re-abstracting study - what is it?
qualified staff member abstracts the sample case again from medical records that is compared to the OG discrepancies bt can be identified as MINOR or MAJOR
87
Data quality activities: text documentation - it is a vital aspect of what? and it must do what?
data COMPLETENESS must tell story in language that supports coding
88
Data quality activities: why is text the most important tool for central reg?
it is used for reconsiling conflicting codes from different sources during the CONSOLIDATION process
89
Data quality activities: Unknown values and ill-defined codes pose problems to data analysis. why? what does a high rate of unknown codes indicate? what does low rates of unknown codes indicate?
it can skew data in a way thay may for example rep. more of a given pop sources of information are being overlooked registrar may be making unsupported assumptions about data (rate of uknowns should be somewhat stable)
90
What data field has the greatest number of missing/unknown values?
grade
91
Reports ensuring timeliness: comparitive coding can monitor what? how is it measured?
consistency reliability studies
92
What is a lag time report?
report that tracks cases by date of dx against date of received in central reg
93
How often are timeliness standards monitored for being met? and how?
monthly by timeliness reports
94
Reports ensuring timeliness: what does a reliability study test? what does it help with?
registry rules and measures whether rules provide consistent and reliable guidance so coding the same case by diff. registars is consistent study helps find areas where coding rule documentation is unclear
95
Completeness: casefinding audits ensure _____ and guards against ____
case incidence completeness duplication of cases
96
comleteness rate (%) = 100 - [(missed cases/total # identified) *100]
casefinding audit
97
missed rate = (# missed total/#identified) *100
casefinding audit
98
Completeness: historical data review = what?
comparing # of cases expected based on previous years or on standard incidence rates and those observed
99
why would a historical data review be done?
cheap can indicate changes in case completeness over time
100
if central reg accepts all submitted records and does not check for quality of data this could result in what?
greater case completeness but poorer quality
101
no matter what kind of case rejection criteria a central reg uses, this should be in place to ensure resubmission of those cases to the registry
follow-up
102
what activities do central reg use to ensure ACCURATE and COMPLETE data
audit on casefinding, consolidation, reabstraction, recoding de-duplication manual record consolidation process monitoring
103
this certification provides objective measure of DATA QUALITY, COMPLETENESS AND TIMELINESS when looking at other registries
NAACCR certification
104
Four audit types that central reg perform on facilities
casefinding audit consolidation audit re-abstracting audit recording audit
105
reliability studies are conducted from central reg on facilities to assess
reproducibility (cancer registrars) and validity (source documents)
106
what is the initial type of audit that a central reg will perform if they suspect underreporting?
casefinding
107
when central reg performs audits, what do they do with this information
they inform the hosp reg for correction and education opportunity
108
what kind of cases do central reg often choose for audits (x2)
sources of high quantity (top primary site for ex) sources with high risk of missed cases (new practices reporting or bone marrow transplant from hospital for ex)
109
what is purpose of de-duplication
evaluates number of duplicate record in the CENTRAL regy database that have not been identified or corrected using matching, linkages or other protocols
110
de-duplication is the process of ____ ____ in the CENTRAL reg database that are recorded as __________
identifying individuals recorded as two or more people or same person having mutiple primaries when they have a single
111
how are duplicate identified on matchin
name, DOB and SSN then reviewing the other variables
112
how are duplicate records tracked
Identificatioin of Duplicates Form
113
what is the most common activity of the central reg in regard to QUALITY CONTROL of the RECORD CONSOLIDATION PROCESS
running of data quality and inter-record edits after consolidation is complete
114
QI goes beyond data ____ and looks at what?
ACCURACY systems and processes that affect accuracy of data and performance indicators
115
QA measures ____ while QI examines ____
QA measures accuracy QI examines the causes behind inaccuracies and changes that can be made to reduce errors
116
Process improvement is also called
performance improvement
117
QI Methodologies: PDSA/PDCA - Plan, Do, Study/Check, Act is often used for testing effectiveness of change/intervention for
small or limited scale items
118
PDSA is usually depicted as a cycle, why?
intended to be repeatedly checked small incremental changes
119
Which QI methodology is best applied to rapid-cycle processes
PDSA/PDCA
120
Outline PDSA steps
P - Plan by defining problem and desired outcome D - Implement the change or intervention S - Analyze data collected and compare to before intervention A - Use the results for S step to plan the NEXT step
121
QI Methodologies: DMAIC means
Define Measure Analyze Improve Control
122
This QI methology is a six sigma method
DMAIC
123
DMAIC is typically used for ...
larger scale projkect where careful planning is needed
124
This QI methology relies heavily on data to get to the root of the problem
DMAIC
125
What does LEAN offer by reducing waste
efficiency
126
What are the two types of tools for QI
Idea driven and data driven
127
What are the 7 tools of QI
Cause and effect diagram Check sheet Flowchart Histogram Pareto chart Run chart Scatter plot
128
Cause and effect diagram is good for what/not the best for what
identifiying all possible causes the primary cause
129
Check sheets are used to document ____ over time
OCCURENCES
130
What are check sheets useful
finding trends and patterns over time
131
Flowcharts is a diagram of _____ and used to identify _____ ______
multistep process redundencies and delays
132
This QI tool looks start and end points and steps and decisions between the two
flowchart
133
This QI tool is represents FREQUENCY of events over DISCRETE categories
histogram
134
Parteo charts different from histogram in what 2 ways
bars of pareto go from largest to smallest a line shows cumulative % of total represented area on the pareto
135
This QI tool identifies primary causes of a problem to priortize improvement interventions
pareto chart
136
This QI tool is a line graph of data over time and used to identify what?
run chart variations in a process or measure
137
extreme variation in a run chart could indicate
need for improvement
138
This QI tool shows the relationship between two CONTINUOUS variables
scatter plot
139
where should the CQI process be housed
cancer reg's policy and procedure manua
140
Process monitoring requires what to determine the NATURAL VARIABLILITY of measures whether the move way out of range
statistical evaluation
141
Common MANAGEMENT REPORTs for a cent reg include (x5)
data submissions timeliness interval bt date of dx and submission # and type of errors % unknowna and unspecific values completeness
142
Why are productivity standards important in regard to QI?
helps meet state and national deadlines
143
___ and ___ are used to determine staffing and productivity levels
workflow and workload
144
This is an ordered list of all steps needed to complete a task (mapping of workflow)
step assessment
145
step assessment vs workflow chart
step = simple linear process workflow chart = complex processes
146
once a step assessment or workflow chart is complete this can be performed to measure time requird for each step
time and motion study
147
Casefinding at the facility level is the process of identifying cases that need to be reported to ... and for CoC facilities reported to...
central cancer registry NCDB
148
Where does one get information on the casefinding process?
policy and procedure manual of the dept
149
When is an accession # assigned
when picked up from casefinding, moved from suspense to the registry to begin abstracting
150
What is difference between analytic cases and nonanalytic (class of case)?
analytic required by CoC to be abstracted non-analytic may be abstracted to meet CENTRAL regy requirements OR REPORTABLE BY AGREEMENT requests
151
What are the 3 main, primary casefinding sources? Which is #1?
path reports - #1 med/rad oncology logs - treatment summaries HIM disease indices
152
What could be included in a path reports? (4)
surgical specimens cytology bone marrow biopsies autopsy reports
153
Most hospital registries abstract cases within how many months of what?
6 months date of first contact
154
What doise the ICD-O behavior code have to be to be reportable?
/2 /3 behavior
155
What is the most important use of the disease index
identify cases not found through other means
156
What are the 4 factors for determining if a case is eligible for inclusions (pulled from suspense file to abstract)
dx primary site reference date reason for visit
157
What is the reference date?
effective date which cancer registration began for the facility it is always january 1st for month and day anything after reference date must be reported
158
What is the case completeness goal for central registries?
95%
159
Explain death clearance and when this occurse for whom
central regy at end of year compares/links to their database those who died that year compared to those alive cancer pts in registry info comes from mortality files from state dept of vital statistics
160
What is an abstract?
Info on pt from dx to death
161
What is the abstracting time frame?
pt initial contact with institution with a reportable dx to completion of abstract based on date of 1st contact, not dx
162
What is concurrent abstracting?
abstracting as information becomes available
163
Who owns the RCRS - Rapid Cancer Reporting System? what did it replace?
COC Rapid Quality Reporting System
164
Write the accession # for bx positive pt in January 2020 and was the 3rd case of the year
20200003
165
What is the year in the accession #
year which pt was seen in the reporting facility
166
When thinking of the accession #, if they come back years later for a new primary, what is done?
the same accession number is used for all additional primaries
167
What is the sequence #?
identifies seperate primaries for each pt
168
What happens to an accession # of pt where the found out it was actually not reportable?
delete it
169
other than who it is reportable to, what dose class of case tell you?
identifies the interaction pf has with YOUR REPORTING facility
170
1st course of tx is
tx given or PLANNED at time of intitial dx
171
What is case administration
overide flags and identifies coding system used to abstract the case, version of coding manual used, reporting institution and CTR who coded
172
Who provides and is the only one to receive text accompanying an abstract
central registry
173
Cancer incidence definition
Number of new cancer cases occurring in a defined population in a defined period of time
174
Incidence vs. prevalence
Incidence tells us how many new cases of cancer are being diagnosed. Prevalence tells us how many people in total have cancer at a certain time. Imagine a bucket filling with water: Incidence measures how fast water is pouring into the bucket. Prevalence measures how much water is already in the bucket at any given moment.
175
What are the purposes of staging? (3)
1. assess extent of cancer to effectively treat 2. prognosis 3. comparing institution data with national data
176
Who owns Summary Stage?
NCI SEER
177
What should registrar do if staging doesn't match that of the managing physician?
consult with doctor to see if additional documentation exists
178
What must doctor state to denote LNs are affected... This applies to all cancers except what?
"involved" - not enlargement lymphomas
179
Endoscopic is what?
inserted into internal passages or hollow organs and viscera
180
What are prognostic factors Give examples of prognostics factors
tumor markers diseases like HPV or Crohn's lab tests like CEA, CA19-9, CgA, LDH, Ki 67 genetic factors like HER2, KRAS, 18q loss (LOH)
181
What does ER PR tell you
estimate potential response to endocrine (hormone) therapy they are both steroid hormone receptors determinates in prognosis denotes whether cancer is growin in presence of either or both naturally occuring hormones
182
CEA tumor marker is associated with what cancers (4)
colon, lung, breast, pancreas
183
CA125 tumor marker is associated with what cancer
ovarian
184
AFP tumor marker is associated with what cancers (2)
seminoma testicular cancer and some ovarian
185
hCG hormone tumor marker is associated with what cancers (4)
germ cell tumors, breast, choriosarcoma, testicle
186
Who developed the SOR (synoptic operative report)
Cancer Surgery Standards Program of ACoS
187
Bypass surgeries create a passage around a tumor often for palliation. What does the ending prefix?
-otomy gastrotomy, cystotomy, laparotomy, thoracotomy
188
Difference between incision bx and excisional
incisional removes portion of tissue excisional attempts to remove tumor
189
___ takes prescedence over preliminary reports and frozen sections
final diagnosis
190
___ takes prescedence over gross descriptions when determining involvement
microscopic
191
another name fo rmultifocal tumors
multicentric
192
thoracentesis vs paracentesis
thora = thoracic = lung / para is puncture in abdominal cavity to remove fluid
193
Summary stage is most often used by _____ as it rarely changes of time / has longtitudinal stability
population based regys
194
What is difference between stage group and prognostic stage group
Stage group = TNM, Prognostic stage group includes biomarkers, anatomy and other prognostic factors
195
Extent of disease is this, not this and is used by who
coding system, not staging system central registries and it uses algorithms to determine stage based on codes
196
Ann Arbor system is for what and what did it become
staging Lymphomas Ann Arbor > Lugano classification
197
What is grade What are the traditional categories before they varied by site
measure of aggressiveness of tumor & is prognostic factor well diff, mod diff, poor diff, undiff/anaplastic
198
Who developed grade coding tables and SSDIs
NAACCR
199
What did SSDI used to be called and when were they established
2004, SSF site specific factors
200
What are the 3 major forms of curative treatment?
surgery, radiation, systemic
201
What 3 categories of systemic tx
chemo, hormone, immuno
202
What is it called when you give multiple tx types at once
multimodality
203
Who creates the standard tx guidelines
NCCN Natl Comprehensive Cancer Network
204
Explain NOTES surgery
natural orifice transluminal endoscopic surgery minimally invasive, through natural orifice using endoscopy
205
Radiofrequency abalation (RFA) uses what
heat energy (heated with radiofrequency waves
206
name a form of laser therapy
photodynamic therapy - photosenstitizing agent is injected, absorbed by cancer cells, 2 days late light ablates
207
what is another name for endocrine surgery
surgical ablative therapy
208
IMRT is a specialized form of what
3d conformal therapy
209
stereotactic xrt is used for name a type
brain lesions gamma knife
210
name the common type of partial breast intraCAVITARY radiation
mammosite
211
most commonly used isotope for brach
I-131 - for thyroid
212
What is isotope Phosphorus 32 (32P) given for (3)
polycythemia vera, malignant ascites, malignant pleural effusion
213
Strontium 89 (89SR) isotope is deritive of calcium and collects in osteoblastic lesions. what is most used for?
bone mets
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INTRA chemo methods: loosely outline them intravenous administration *** intraperiotoneal intra-arterial intraventricular intrathecal intramuscular
intravenous administration *** most common - uses pump and chronic venous access intraperiotoneal - b/t muscles and organs in abdomen intra-arterial - aka chemoembolization - Gelfoam w/ chemo inserted into atery intraventricular - circumvents blood brain barrier (into CNS) - given by lumbar puncture intrathecal - circumvents blood brain barrier (into CNS) - given by lumbar puncture intramuscular - into the muscle, such as Xeloda and Temodar or topical for Mycosis fung.
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3 BM transplant types
allogenic - donor cells from another person (matched relative) syngeneic - type of allogenic, cells from identical twin autologous - from own bone marrow
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Name 2 other systemic therapies that are coded as chemo
Imatinib aka Gleevec - targeted therapy for CML and GIST Bortezomib aka Velcade - apoptosis inducing drug (not chemo)
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Endocrine therapy ANTIs - name a few antiestrogen (3) antiandrogen (4) anticorticoids
antiestrogen - tamoxifan, arimidex & Aromotase Inhibitors like AG - breast and prostate antiandrogen - Casodex, Flutamide, Lupron, Zoladex - prostate anticorticoids - prednisone, Decadron - heme cases
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Thyroid tx Levothyroxine (Synthroid) and liothyronine (Cytomel) should be coded as what
hormonal tx when give after total thyroidectomy for papillary carcinoma
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Megestrol (Megace) is traditional used for ___ but also used for ___
breast hormonal agent, but also for appetite stimulant for all cancers
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Other names for immunotherapy
biological therapy or BRMs - biological response modifiers
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What does immunotherapy do
uses bodys immune system to fight cancer
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Name some BRMs/immunotherapies and what they treat
Rituxan - NHL Herceptin - HER2+ breast cancer
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"mab" ending drugs are what? what should they be coded to?
-monoclonal antibodies -coded to immunotherapy
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Types of IMMUNOTHERAPIES 1. interferons (IFNS) 2. interleukins (ILs) 3. colony stimulating factors (CSFs) 4. tumor necrosis factor (not widely used) - X 5. cancer vaccines
1) IFN alpha leukemias, melanoma, AIDS related KS, kidney cancer 2) ILs - metastic kidney and metastatic melanoma 3) CSFs aka GROWTH FACTORS, encourages BM stem cells ex. erythropoietin 5) Gardasil
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Alternative therapies that are unproved should be coded as
unproven treatment
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What must be done with studies before they report cancer registry data to RESEARCHERS
IRB approval
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Name a few areas in which cancer registries overlap with clinical research departments
DATA DRIVEN -data is used to form research projects -QA studies -QI implementation -User defined fields -AJCC stage -Tumor markers -Demographics
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What does the IRB do
group who reviews and monitors research involving HUMAN subjects
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Who protects the rights and welfare of human research subjects
IRB
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IRB reviews can be any of these 3 things depending on the level of risk to the patient
expedited, exempt, require full board review
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Who is a PI
Principal Investigator with IRB They are in charge of a clinical investigation Carries out the clinical trial protocol, analyzes the data and reports **almost always a doctor
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Who carries out the IRB research protocols
research staff / team
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Research can be either interventional or non-interventiional. what is the difference
non-interventional means that pt does not receive a therapeutic intervention
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The ACoS Cancer Research Program (CRP) conducts SPECIAL STUDIES through CoC accredited programs. What do these studies do
evaluate patient care set benchmarks provide feedback for improving patient care
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clinical trial where ONLY the RESEARCHER doing the study knows which tx or intervention the particpant is receiving until trial is over
single blind study
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exploratory study often using only a few small doeses of a new drug in a few paties
phase 0 clinical trial
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study is done to find the highest dose of new tx that be given safely without serious side effects
phase 1 clinical trial
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if tx if found to be reasonably safe, it can now be tested for effectiveness in this trial
phase 2 clinical trial
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if tx works, researchers compare safety and effectiveness of new tx against current tx standards in this trial
phase 3 clinical trial
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this trial type looks at drugs already FDA approved - with important questions still needing to be answered
phase 4 clinical trial