Proposed Changes to Currently Approved MDE Data Set

OMB_Attachment 04 (MDE60changes).pdf

Minimum Data Elements for the National Breast and Cervical Cancer Early Detection Program

Proposed Changes to Currently Approved MDE Data Set

OMB: 0920-0571

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ATTACHMENT 4
Proposed Changes to the Currently-Approved MDE Data Set

MDE Version 6.0 Changes

New
MDE
Item
Number

Old
MDE
Item
Number

Variable Name

Change(s)

Reason for change / Usage

Note: All variables were renumbered due to significant changes in the MDE structure, and to allow for future additions to be easily incorporated.
Any reference in the Data Definition Table to the old item number was updated to reflect the new item number. Due to the volume of those changes,
they are not individually noted in this changes document.
Additional Edit Check/Skip Pattern guidance was provided to further clarify the MDE Item intent. Due to the volume of those additions, they are not
individually noted in this changes document.
All Patients Section

2.02

1c

City

Removed this field.

Not used.

1e

Pap Test Screening
Site

Removed this field.

Not used.

1f

Mammogram
Screening Site

Removed this field.

Not used.

1.g

Reserved

Removed this field.

Not used.

2.b

Record ID

Changed from a 6 to 8 digit field.

Expanded to allow more user versatility.

2.c

Record Type

Removed this field.

Not used.

3.e

Reserved

Removed this field.

Not used.

3.g.6

Race 6

Removed this field.

Not used.

12/04/2007

2

MDE Version 6.0 Changes
New
MDE
Item
Number

Old
MDE
Item
Number

Variable Name

Change(s)

Reason for change / Usage

5.03

Indication for Pap Test

New field added to report purpose for Pap
test.

Distinguish a traditional screening cycle from other
types.
Improve translation of clinical data to MDE record.
Improve precision of Edits Program checks,
data analyses and outcome reporting.

5.04

Cervical Diagnostic
Referral Date

New field added to report date client was
referred to program for diagnostic workup
following an abnormal screen provided
outside of the program network.

Added to calculate time to diagnosis for those
women referred for diagnostic evaluation after
being screened outside of the program network.

5.07

4.g.3

Specimen Type

Moved so it now follows the Specimen
Adequacy field, to keep related fields
together.

Relocated to improve record flow.

5.08

4.g.2

1991 Pap Test Result

Removed the following Results:
(9) Not Needed
(10) Needed Not Performed
(13) Done Recently Elsewhere

These categories are now captured in 5.03
Indication for Pap Test.

5.09

4.g.4

2001 Pap Test Result

Removed the following Results:
(9) Not Needed
(10) Needed Not Performed
(13) Done Recently Elsewhere

These categories are now captured in 5.03
Indication for Pap Test.

5.13

HPV Test Result

New field added to collect HPV test result.

New funded procedure.

5.14

Date of HPV Test

New field added to collect HPV test date.

New funded procedure.

12/04/2007

3

MDE Version 6.0 Changes
New
MDE
Item
Number

Old
MDE
Item
Number

Change(s)

Reason for change / Usage

HPV Test Paid by
NBCCEDP Funds

New field added to report if an HPV test was
paid using NBCCEDP funds.

New funded procedure. Payment information
collected for all NBCCEDP funded screening tests.

Diagnostic Work-up
Planned for Cervical
Dysplasia or Cancer

Moved so it now follows the HPV Test Paid
field, in order to maintain appropriate flow.

Relocated to maintain record flow.

6.03

Indication for Initial
Mammogram

New field added to report purpose for initial
mammogram.

Distinguish a traditional screening cycle from other
types.
Improve translation of clinical data to MDE record.
Improve precision of Edits Program checks
data analyses and outcome reporting.

6.04

Breast Diagnostic
Referral Date

New field added to report date client was
referred to program for diagnostic workup
following an abnormal screen provided
outside of the program network.

Added to calculate time to diagnosis for those
women referred for diagnostic evaluation after
being screened by a provider outside of the
program network.

5.15

5.16

4.g.6

12/04/2007

Variable Name

4

MDE Version 6.0 Changes
New
MDE
Item
Number

Old
MDE
Item
Number

6.05

4.k

Variable Name

Initial Mammography
Test Result

Change(s)

Reason for change / Usage

Category 3 “Probably Benign” was modified
to include an asterisk indicating this
assessment requires prior full imaging workup.

Improve documentation in Data Definition to
acknowledge recent BI-RADS-3 changes. This will
not impact the MDE follow-up algorithm because
MDEs do not contain enough clinical history to
adequately monitor appropriate use of BIRADS-3
assessment.

Category 6 “Assessment Incomplete” was
separated into two MDE categories:
(6) Assessment is Incomplete – Need
additional imaging evaluation’
(13) Film Comparison Required’

The distinction between a mammogram result
needing additional procedures and one that is
“pending” a film comparison will allow the CDC to
evaluate true Assessment Incomplete. Category
13 replaces previous MDE coding guidance to
code test result as pending while awaiting a
required prior film comparison.

Removed the following Results:
(8) Not Needed
(9) Needed Not Performed
(12) Done Recently Elsewhere

These categories are now captured in 6.03
Indication for Mammogram.

The Edit Checks/Skip Patterns field was
modified to reflect changes in the Additional
Breast Procedures Section.
6.08

4.k.1

Additional Procedures
Needed to Complete
Breast Cycle

Title of field changed from “Diagnostic
Work-up Planned for Breast Cancer” to
“Additional Breast Procedures Needed to
Complete Breast Cycle”.

The Abnormal Breast section has been separated
into two categories (1) additional imaging, with a
final imaging result and (2) diagnostic tests.

6.09

4.n

MDE Version Number

Category ‘60’ was added.

Added to reflect new MDE version.

12/04/2007

5

MDE Version 6.0 Changes
New
MDE
Item
Number

Old
MDE
Item
Number

Variable Name

Change(s)

Reason for change / Usage

Abnormal Pap Test Section
Section name changed to “Additional Cervical Procedures Section” to be more consistent with naming convention for the Breast Diagnostic
Procedures Section.
7.02

1.a.2

Colposcopy with
Biopsy and/or ECC

Field name was changed to indicate that
when a biopsy and/or an ECC is performed
in conjunction with a Colposcopy, this field
should be completed as ‘Yes’.

This change allows for better clinical reporting.

7.03

LEEP

New field added to report LEEP procedures
performed.

New funded procedure.

7.04

Cold Knife Cone
(CKC)

New field added to report CKC procedures
performed.

New funded procedure.

7.05

Endocervical curettage
alone (ECC)

New field added to report stand alone ECC
procedures performed.

This change allows for better clinical reporting.

7.06

1.a.3

Other Cervical
Procedures Performed

Name of field updated to be consistent.

7.07

1.a.3

Other Cervical
Procedures Performed
Description

Name of field updated to be consistent.

12/04/2007

The two “Other Cervical Procedures
Performed Description” fields were merged
into one free text field.

6

MDE Version 6.0 Changes
New
MDE
Item
Number

Old
MDE
Item
Number

8.01

1.c

8.02

1b

Variable Name

Status of Final
Diagnosis

Final Diagnosis

Change(s)

This field was moved so it now precedes the
Final Diagnosis (8.02) field, in order to keep
related items together and maintain
appropriate flow.

Relocated to maintain record flow.

Added a response category “9 Irreconcilable”.

A response of “9” will be used for those cases,
which after clinical review; it is found that there is
no sufficient way to translate the clinical scenario
into the MDE data record. This value will be used
to help minimize the Standard Audits to only those
records that need to be reviewed.

Added guidance that Adenocarcinoma of
cervix should be coded as “6 – Invasive
Cervical Carcinoma”.

Adenocarcinoma of the cervix is an invasive
cancer that needs to be treated, as well as
Adenocarcinoma In Situ of the cervix. Providing
guidance on the proper coding of these findings
will allow the CDC to monitor that treatment was
started.

Added guidance that Adenocarcinoma In
Situ of the cervix should be coded as “5 –
CIN3/Severe Dysplasia/CIS/AIS”
8.05

1.b.6.a

12/04/2007

Stage at Diagnosis

Reason for change / Usage

This field has been superseded by the new
registry section. Historical (legacy) data
should remain in the database. The new
Collaborative Stage (CS) data fields must
be completed for all women screened as of
January 1, 2009.

The CDC will utilize Registry data for staging
analyses. Programs who are not able to link with
their state cancer registries should notify the CDC
and IMS.
Programs may choose to continue collecting and
reporting pathological data in this field, however
CDC analyses (DQIG, Standard Audits, etc) will be
generated using the Collaborative Stage fields.

7

MDE Version 6.0 Changes
New
MDE
Item
Number

Old
MDE
Item
Number

Variable Name

Change(s)

Reason for change / Usage

Abnormal CBE/Mammogram Section
Section name changed to “Additional Breast Procedures” to allow for a new sub-division of
the diagnostic procedures into two unique groups: Breast Imaging Procedures and Breast
Diagnostic Procedures. This allows for the reporting of follow-up using imaging only vs. followup to identify etiology of a suspicious lesion.
Additional Mammographic Views (10.01) and Ultrasound (10.02) were moved from “Breast
Diagnostic Procedures” into the new subcategory of “Breast Imaging Procedures”.
10.03

Film Comparison to
evaluate an
Assessment
Incomplete

New field added to indicate if a film
comparison was required and performed to
obtain a final imaging outcome.

The distinction between a mammogram result
needing additional procedures and one that is
“pending” a film comparison will allow the CDC to
evaluate true Assessment Incomplete.
A film comparison will be sufficient follow-up to
complete an Assessment Incomplete mammogram
with a Final Imaging Outcome that requires no
further diagnostic evaluation.

10.04

Final Imaging
Outcome

New field added to provide a final imaging
diagnosis based on additional views and/or
film comparison.

Provides critical information on imaging outcomes,
not previously available, particularly an issue for
BIRADS-0.

10.05

Date of Final Imaging
Outcome

New field added to collect date of final
imaging diagnosis.

Provides critical information on imaging outcomes,
not previously available, particularly an issue for
BIRADS-0.

Other Breast
Procedures Performed

Name of field changed to be consistent.

11.04

1.a.6

12/04/2007

8

MDE Version 6.0 Changes
New
MDE
Item
Number

Old
MDE
Item
Number

11.05

1.a.6

12.01

12.03

1.c

1.d

12/04/2007

Variable Name

Change(s)

Reason for change / Usage

Other Breast
Procedures Performed
Description

Name of field changed to be consistent.

Status of Final
Diagnosis/Imaging

Renamed variable to include “Imaging”
based on the subdivision of additional
imaging and additional diagnostic tests.

Renamed to more accurately describe patient
follow-up.

Added a response category “9 –
Irreconcilable”.

A response of “9” will be used for those cases,
which after clinical review; it is found that there is
no sufficient way to translate the clinical scenario
into the MDE data record. This value will be used
to help minimize the Standard Audits to only those
records that need to be reviewed.

This field was moved so it now precedes the
Final Diagnosis (12.02) field, in order to
keep related items together and maintain
appropriate flow.

Improve record flow.

Renamed variable to include “Imaging”
based on the subdivision of additional
imaging and additional diagnostic tests.

Renamed to more accurately describe patient
follow-up.

This field was moved so it now follows the
Final Diagnosis (12.02) field, in order to
keep related items together and maintain
appropriate flow.

Improve record flow.

Date of Final
Diagnosis/Imaging

The two “Other Breast Procedures
Performed Description” fields were merged
into one free text field.

9

MDE Version 6.0 Changes
New
MDE
Item
Number

Old
MDE
Item
Number

12.04

1.b.2.a

12.05

1.b.2.b

Variable Name

Stage at Diagnosis

Tumor Size

Change(s)

Reason for change / Usage

This field has been superseded by the new
registry section. Historical (legacy) data
should remain in the database. The new
Collaborative Stage (CS) data fields must
be completed for all women screened as of
January 1, 2009.

The CDC will utilize Registry data for staging
analyses. Programs who are not able to link with
their state cancer registries should notify the CDC
and IMS.

This field will not be evaluated by the CDC.
Historical (legacy) data should remain in the
database, however for all women screened
as of January 1, 2009 the new Collaborative
Stage (CS) data fields must be completed.

The CDC will utilize Registry data for staging
analyses. Programs who are not able to link with
their state cancer registries should notify the CDC
and IMS.

Programs may choose to continue collecting and
reporting pathological data in this field, however
CDC analyses (DQIG, Standard Audits, etc) will be
generated using the Collaborative Stage fields.

Programs may choose to continue collecting and
reporting pathological data in this field, however all
CDC analyses (DQIG, Standard Audits, etc) will be
generated using the Collaborative Stage fields.

12/04/2007

10

MDE Version 6.0 Changes
New
MDE
Item
Number

Old
MDE
Item
Number

Variable Name

Change(s)

Reason for change / Usage

Cervical Cancer Registry Data
14.01

Registry Linkage
Status

New field added to indicate if the record has
been linked with Cancer Registry data.

Monitor access to registry data.

14.02

Registry Date of
Diagnosis

New field added to indicate the Date of
Diagnosis as reported by the Registry.
NAACCR data item #390.

Standardize collection of stage data to improve
outcome reporting.

14.03

Registry Histologic
Type

New field added to indicate Histology Type
as reported by the Registry. NAACCR data
item #522.

Standardize collection of stage data to improve
outcome reporting.

14.04

Registry Behavior

New field added to indicate Behavior as
reported by the Registry. NAACCR data
item #523.

Standardize collection of stage data to improve
outcome reporting.

14.05

Registry Summary
Stage

New field added to indicate Summary Stage
as reported by the Registry. NAACCR data
item #3020, #759 or #760 depending on
Registry Date of Diagnosis.

Standardize collection of stage data to improve
outcome reporting.

14.06

Registry CS Derived
AJCC Stage Group

New field added to indicate derived AJCC
stage group as reported by the Registry.
NAACCR data item #3000.

Standardize collection of stage data to improve
outcome reporting.

14.07

Registry CS Tumor
Size

New field added to indicate Tumor Size as
reported by the Registry. NAACCR data
item #2800.

Standardize collection of stage data to improve
outcome reporting.

12/04/2007

11

MDE Version 6.0 Changes
New
MDE
Item
Number

Old
MDE
Item
Number

Variable Name

Change(s)

Reason for change / Usage

14.08

Registry CS Extension

New field added to indicate extension of
disease as reported by the Registry.
NAACCR data item #2810.

Standardize collection of stage data to improve
outcome reporting.

14.09

Registry CS Lymph
Nodes

New field added to indicate lymph node
involvement as reported by the Registry.
NAACCR data item #2830.

Standardize collection of stage data to improve
outcome reporting.

14.10

Registry CS Mets at
Diagnosis

New field added to indicate metastatic
involvement as reported by the Registry.
NAACCR data item #2850.

Standardize collection of stage data to improve
outcome reporting.

14.11

Registry Primary Site

New field added to indicate primary site as
reported by the Registry. NAACCR data
item #400.

Standardize collection of stage data to improve
outcome reporting.

Breast Cancer Registry Data
15.01

Registry Linkage
Status

New field added to indicate if the record has
been linked with Cancer Registry data.

Monitor access to registry data.

15.02

Registry Date of
Diagnosis

New field added to indicate the Date of
Diagnosis as reported by the Registry.
NAACCR data item #390.

Standardize collection of stage data to improve
outcome reporting.

15.03

Registry Histologic
Type

New field added to indicate Histology Type
as reported by the Registry. NAACCR data
item #522.

Standardize collection of stage data to improve
outcome reporting.

12/04/2007

12

MDE Version 6.0 Changes
New
MDE
Item
Number

Old
MDE
Item
Number

Variable Name

Change(s)

Reason for change / Usage

15.04

Registry Behavior

New field added to indicate Behavior as
reported by the Registry. NAACCR data
item #523.

Standardize collection of stage data to improve
outcome reporting.

15.05

Registry SEER
Summary Stage

New field added to indicate SEER Summary
Stage as reported by the Registry.
NAACCR data item #3020, #759 or #760
depending on Registry Date of Diagnosis.

Standardize collection of stage data to improve
outcome reporting.

15.06

Registry CS Derived
AJCC Stage Group

New field added to indicate derived AJCC
stage group as reported by the Registry.
NAACCR data item #3000.

Standardize collection of stage data to improve
outcome reporting.

15.07

Registry CS Tumor
Size

New field added to indicate Tumor Size as
reported by the Registry. NAACCR data
item #2800.

Standardize collection of stage data to improve
outcome reporting.

15.08

Registry CS Extension

New field added to indicate extension of
disease as reported by the Registry.
NAACCR data item #2810.

Standardize collection of stage data to improve
outcome reporting.

15.09

Registry CS Lymph
Nodes

New field added to indicate lymph node
involvement as reported by the Registry.
NAACCR data item #2830.

Standardize collection of stage data to improve
outcome reporting.

15.10

Registry CS Mets at
Diagnosis

New field added to indicate metastatic
involvement as reported by the Registry.
NAACCR data item #2850.

Standardize collection of stage data to improve
outcome reporting.

12/04/2007

13

MDE Version 6.0 Changes
New
MDE
Item
Number

Old
MDE
Item
Number

15.11

12/04/2007

Variable Name

Registry Primary Site

Change(s)

New field added to indicate primary site as
reported by the Registry. NAACCR data
item #400.

Reason for change / Usage

Standardize collection of stage data to improve
outcome reporting.

14


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