Colorectal Cancer Clinical Data Elements

Colorectal Cancer Screening Program

0920-05CJ ATTACHMENT 2a CCDE Data Definition Table v100-20060206

Attachment 2a. Colorectal Cancer Clinical Data Elements for FOBT Programs

OMB: 0920-0745

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Colorectal Cancer Clinical Data Elements (CCDEs)

Data Definition Table




Table of Contents:


Section 1 Program and Enrollment Data 2


Section 2 Client and Record Identification 4


Section 3 Demographic Information 4


Section 4 Screening History 6


Section 5 Colorectal Cancer Risk Factors 8


Section 6 Screening and Diagnostic Tests Provided 9


Section 7 Diagnosis Information for All Polyps/Lesions 21


Section 8 Diagnosis Information for Surgeries Performed to Complete Diagnosis 52


Section 9 Final Diagnosis 53


Section 10 Diagnosis Information for Cancer/High Grade Dysplasia 55


Section 11 Treatment Information 57


Section 12 Record Information 57


Public reporting burden of this collection of information is estimated to average one hour per submission, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer, 1600 Clifton Road, MS-24, Atlanta, GA 30333, ATTN: PRA (xxxx-xxxx).



Form Approved

OMB No. 0920-xxxx

Exp. Date_________

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

1. Program and Enrollment Data – Complete for each CCDE record

1.1


Program


Unique identifier for each program.

3

1

3

001 = Baltimore, MD

002 = St. Louis, MO

003 = State of NE

004 = Stony Brook, NY

005 = Seattle and King County, WA

Valid code for your program.

1.2

Date of eligibility


The date that the client was determined to be eligible to be screened in the program. This could be the date of the initial interview or the date that an enrollment form was filled out.

8

4

11

MMDDYYYY


If just the year is known, blank fill the month and day. If just the year and month are known, blank fill the day (e.g. 04 2006).

MMDDYYYY”, “MM YYYY” or “YYYY”, but not blank.

1.3.1

Knowledge of program (1)


Indicates how client learned about the program.

2

12

13

1 = Doctor

2 = Other health care provider

3 = NBCCEDP

4 = Family member

5 = Friend

6 = Radio

7 = Television

8 = Magazine article

9 = Newspaper

10 = Mailing/flyer

11 = Community event

12 = Other


Right justify

Range check.

1.3.2

Knowledge of program (2)


Indicates how client learned about the program.


Use this field if client indicates that he/she learned about the program from more than one source.

2

14

15

1 = Doctor

2 = Other health care provider

3 = NBCCEDP

4 = Family member

5 = Friend

6 = Radio

7 = Television

8 = Magazine article

9 = Newspaper

10 = Mailing/flyer

11 = Community event

12 = Other


Right justify

Range check.

1.3.3

Knowledge of program (3)


Indicates how client learned about the program.


Use this field if client indicates that he/she learned about the program from more than two sources.

2

16

17

1 = Doctor

2 = Other health care provider

3 = NBCCEDP

4 = Family member

5 = Friend

6 = Radio

7 = Television

8 = Magazine article

9 = Newspaper

10 = Mailing/flyer

11 = Community event

12 = Other


Right justify

Range check.

1.3.4

Knowledge of program other text field

25

18

42

If “Knowledge of program” = 12, then enter the description in free text format.


Alphanumeric, left justify

If 1.3.1, 1.3.2 or 1.3.3 = 12, this field should be completed. Otherwise, leave blank.




Reserved for future use

10

43

52


Leave blank.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

2. Client and Record Identification- Complete for each CCDE record

2.1

Client identifier


System generated ID for each client and will be consistent for client throughout database.

15

53

67

If Social Security Number (SSN) is used, it must be encoded. The ID number should be unique and constant for each client in order to track the client over time. This field should not contain any identifiable information, including partial names or dates.


Alphanumeric (no special symbols), left justify

2.2

Record identifier


Each CCDE record identifies a unique CRC “cycle” for a client. A client can have multiple “cycles”.

6

68

73

This field will be used to uniquely identify one record among many for a client. This can be a visit date or a sequential record number.




Numeric, right justify



Reserved for future use

10

74

83


Leave blank.

3. Demographic Information – Complete for each CCDE record, and MUST be self-reported by client

3.1

Date of birth


Date of birth for the client.

8

84

91

MMDDYYYY


If just the year is known, blank fill the month and day. If just the year and month are known, blank fill the day (e.g. 04 2006).

MMDDYYYY”, “MM YYYY” or “YYYY”, but not blank.

3.2

Gender


Indicates gender of client.

1

92

92

1 = Male

2 = Female

9 = Other/unknown

Range check.

3.3

Hispanic or Latino origin


Indicates self-reported Hispanic or Latino origin of client.

1

93

93

1 = Yes

2 = No

9 = Unknown/missing

Range check.

3.4.1

Race 1


The first of five (5) race fields used to capture the self-reported race(s) of a client.

1

94

94

1 = White

2 = Black or African American

3 = Asian

4 = Native Hawaiian or Other Pacific Islander

5 = American Indian or Alaska Native

9 = Unknown


Note: Racial groups are OMB-defined. No primary race is collected. Race 1 has no significance over Race 2-5, and may simply be the first race mentioned.

Range check.


This field should be populated first. If a client self-identifies more than one race, then each race identified should be reported in a separate race field.



3.4.2

Race 2


Complete field if client self-identifies more than one race.

1

95

95

1 = White

2 = Black or African American

3 = Asian

4 = Native Hawaiian or Other Pacific Islander

5 = American Indian or Alaska Native

Range check.


This field should be left blank, unless the client reports more than one race.


3.4.3

Race 3


Complete field if client self-identifies more than two races.

1

96

96

1 = White

2 = Black or African American

3 = Asian

4 = Native Hawaiian or Other Pacific Islander

5 = American Indian or Alaska Native

Range check.


This field should be left blank, unless the client reports more than two races.


3.4.4

Race 4


Complete field if client self-identifies more than three races.

1

97

97

1 = White

2 = Black or African American

3 = Asian

4 = Native Hawaiian or Other Pacific Islander

5 = American Indian or Alaska Native

Range check.


This field should be left blank, unless the client reports more than three races.


3.4.5

Race 5


Complete field if client self-identifies more than four races.

1

98

98

1 = White

2 = Black or African American

3 = Asian

4 = Native Hawaiian or Other Pacific Islander

5 = American Indian or Alaska Native

Range check.


This field should be left blank, unless the client reports more than four races.


3.5

State of residence


Client’s state of residence.

2

99

100

2-digit FIPS code (If unknown, blank fill)



Right justify

Valid FIPS code for state.

3.6

County of residence


Client’s county of residence.

3

101

103

3-digit FIPS code (If unknown, blank fill)



Right justify

Valid FIPS county code for state in 3.5.


Reserved for future use

10

104

113


Leave blank.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

4. Screening History – Complete for each CCDE record, and should be self-reported by client

4.1.1

Previous take-home CRC fecal test (FOBT/FIT)


Self-reported information on most recent previous take-home CRC fecal testing (FOBT/FIT).

1

114

114

1 = Yes

2 = No

9 = Unknown

Range check.

4.1.2

Previous take-home CRC fecal test date


Most recent date (self-reported) for previous take-home CRC fecal test indicated in 4.1.1. This can be any date that the client remembers.

6

115

120

MMYYYY


If just the year is known, blank fill the month (e.g., 2006).

If 4.1.1 = 1, then “MMYYYY” or “YYYY”.


Leave blank if 4.1.1 = 2, 9



4.1.3

Previous take-home CRC fecal test result


Self-reported result of most recent previous take-home CRC fecal test indicated in 4.1.1.

1

121

121

1 = Normal/negative test

2 = Abnormal/positive test result

9 = Unknown

Range check.


Leave blank if 4.1.1 = 2, 9

4.2.1

Previous sigmoidoscopy


Self-reported information on most recent previous sigmoidoscopy.

1

122

122

1 = Yes

2 = No

9 = Unknown

Range check.

4.2.2

Previous sigmoidoscopy test date


Most recent date (self-reported) for previous sigmoidoscopy indicated in 4.2.1.

6

123

128

MMYYYY


If just the year is known, blank fill the month (e.g., 2006).

If 4.2.1 = 1, then “MMYYYY” or “YYYY”.


Leave blank if 4.2.1 = 2, 9



4.2.3

Result of previous sigmoidoscopy


Self-reported result of most recent previous sigmoidoscopy indicated in 4.2.1.

1

129

129

1 = Normal/negative/results other than polyp(s), tumor(s), or cancer

2 = Polyp(s)/tumor(s)/cancer

3 = Incomplete

9 = Unknown

Range check.


Leave blank if 4.2.1 = 2, 9

4.3.1

Previous colonoscopy


Self-reported information on most recent previous colonoscopy.

1

130

130

1 = Yes

2 = No

9 = Unknown

Range check.

4.3.2

Previous colonoscopy test date


Most recent date (self-reported) for previous colonoscopy indicated in 4.3.1.

6

131

136

MMYYYY


If just the year is known, blank fill the month (e.g., 2006).

If 4.3.1 = 1, then “MMYYYY” or “YYYY”.


Leave blank if 4.3.1 = 2, 9



4.3.3

Result of previous colonoscopy


Self-reported result of most recent previous colonoscopy indicated in 4.3.1.

1

137

137

1 = Normal/negative/results other than polyp(s), tumor(s), or cancer

2 = Polyp(s)/tumor(s)/cancer

3 = Incomplete

9 = Unknown

Range check.


Leave blank if 4.3.1 = 2, 9

4.4.1

Previous DCBE


Self-reported information on most recent previous DCBE.

1

138

138

1 = Yes

2 = No

9 = Unknown

Range check.

4.4.2

Previous DCBE test date


Most recent date (self-reported) for previous DCBE indicated in 4.4.1.

6

139

144

MMYYYY


If just the year is known, blank fill the month (e.g., 2006).

If 4.4.1 = 1, then “MMYYYY” or “YYYY”.


Leave blank if 4.4.1 = 2, 9



4.4.3

Result of previous DCBE


Self-reported result of most recent previous DCBE indicated in 4.4.1.

1

145

145

1 = Normal/negative/results other than polyp(s), tumor(s), or cancer

2 = Polyp(s)/tumor(s)/cancer

3 = Incomplete

9 = Unknown

Range check.


Leave blank if 4.4.1 = 2, 9


Reserved for future use

10

146

155


Leave blank.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

5. Colorectal Cancer Risk Factors – Complete for each CCDE record

5.1.1

Personal history of CRC


Has client ever been diagnosed with colorectal cancer?

1

156

156

1 = Yes

2 = No

9 = Unknown

Range check.

5.1.2

Year CRC diagnosed


Year (most recent occurrence) that CRC was diagnosed.

4

157

160

YYYY

If 5.1.1 = 1, then “YYYY”.


Leave blank if 5.1.1 = 2,9


5.2.1

Personal history of polyp(s)


Has client ever been diagnosed with colorectal polyp(s)?

1

161

161

1 = Yes

2 = No

9 = Unknown

Range check.

5.2.2

Largest number of polyps diagnosed during a single procedure

2

162

163

1 – 49 = Number of polyps

50 = ≥ 50 polyps

91 = < 10 polyps (if exact number not known)

92 = ≥ 10 polyps (if exact number not known)

99 = Unknown


Right justify

Range check.


Leave blank if 5.2.1 = 2, 9

5.2.3

Were any of these polyps adenomatous?

1

164

164

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 5.2.1 = 2, 9


5.3

High risk due to family history of CRC


Is this client considered to be at high-risk because of a family history of CRC?*


*Each program will have their own documented definition of high-risk due to family history of CRC.

1

165

165

1 = Yes

2 = No

9 = Unknown

Range check.


Reserved for future use

10

166

175


Leave blank.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

6. Screening and Diagnostic Tests Provided – Complete for each CCDE record

6.0

Initial test recommended


The initial test recommended to the individual by the program.

1

176

176

1 = Take-home FOBT

2 = Take-home FIT

3 = Sigmoidoscopy

4 = Colonoscopy

5 = DCBE

9 = Unknown

Range check.

6.1.0

Indication for 1st test provided


This is the indication for the actual test provided reported in 6.1.01.

Provided = Paid For” (i.e. could be a screening FOBT mailed, but not returned).

1

177

177

1 = Screening

2 = Surveillance after a positive colonoscopy

9 = Unknown

Range check.

6.1.01

1st test provided


The actual first test provided through the program. “Provided = Paid For” (i.e. could be a screening FOBT mailed, but not returned).

1

178

178

1 = Take-home FOBT

2 = Take-home FIT

3 = Sigmoidoscopy

4 = Colonoscopy

5 = DCBE

Range check.



6.1.02

Date of 1st test


Either the date of the procedure, the date that the take-home FOBT/FIT test was processed, or the date the FOBT/FIT results were received.

8

179

186

MMDDYYYY


If just the year is known, blank fill the month and day. If just the year and month are known, blank fill the day (e.g. 04 2006).

MMDDYYYY”, “MM YYYY” or “YYYY”, but not blank.

6.1.03

Provider specialty


The specialty of the clinician providing the 1st test.

2

187

188

1 = General practitioner

2 = Internist

3 = Family practitioner

4 = Gastroenterologist

5 = General surgeon

6 = Colorectal surgeon

7 = Licensed practical nurse

8 = Registered nurse

9 = Nurse practitioner

10 = Physician assistant

11 = Administrator, if FOBT/FIT mailed by non-clinician

99 = Unknown


Right justify

Range check.

6.1.04

Clinical practice site


The type of clinical practice where the 1st test was provided.

1

189

189

1 = Doctor’s office

2 = Ambulatory endoscopy/surgery center

3 = Hospital

4 = Health clinic

5 = Administrator, if FOBT/FIT mailed by non-clinician

9 = Unknown

Range check.

6.1.05

Results of take-home FOBT/FIT


This question is answered if 6.1.01 was a take-home FOBT or FIT.

1

190

190

1 = Normal/negative

2 = Positive

3 = Refused

4 = Did not return card

5 = Pending

9 = Unknown

Range check.


Leave blank if 6.1.01 = 3, 4, 5

6.1.06

Results of endoscopy or DCBE


This question is answered if 6.1.01 was a colonoscopy, a sigmoidoscopy or a DCBE.

1

191

191

1 = Normal/negative/diverticulosis/hemorrhoids

2 = Other finding not suggestive of cancer/polyp(s)

3 = Polyp(s)/suspicious for cancer/presumed cancer

4 = No findings/inconclusive

5 = Pending

9 = Unknown


NOTE: If more than one result, report the worst.

Range check.


Leave blank if 6.1.01 = 1, 2

6.1.07

Was the bowel preparation considered adequate by the clinician performing the endoscopy or DCBE?


This question is answered if 6.1.01 was a colonoscopy, a sigmoidoscopy or a DCBE.


1

192

192

1 = Yes*

2 = No

9 = Unknown



Adequacy will be determined by the clinician performing the test.


*Procedure report must explicitly state that the bowel prep was adequate, otherwise report 9 (Unknown).

Range check.


Leave blank if 6.1.01 = 1, 2

6.1.08

Was the cecum reached during the initial colonoscopy?


This question is answered if 6.1.01 was a colonoscopy.

1

193

193

1 = Yes*

2 = No

9 = Unknown


*Procedure report must explicitly state that the cecum was reached, otherwise report 9 (Unknown).

Range check.


Leave blank if 6.1.01 = 1, 2, 3, 5

6.1.09

Complications of endoscopy or DCBE


This question is answered if 6.1.01 was a colonoscopy, a sigmoidoscopy or a DCBE.

1

194

194

1 = Yes

2 = No/unknown

Range check.


Leave blank if 6.1.01 = 1, 2

6.1.10

Was a biopsy/polypectomy performed during the endoscopy?


This question is answered if 6.1.01 was a colonoscopy or a sigmoidoscopy.

1

195

195


1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 6.1.01 = 1, 2, 5

6.1.11

Number of specimens sent to pathology (from endoscopy)


This question is answered if 6.1.01 was a colonoscopy or a sigmoidoscopy, and a biopsy/polypectomy was performed.


Includes samples removed entirely or in part. If a single polyp is removed piecemeal you would report the number of specimens (not the number of polyps).

2

196

197

0 = Biopsy performed, no specimens sent

1 - 97 = Number of specimens

98 = ≥ 98 specimens

99 = Unknown



Right justify

Range check.


Leave blank if 6.1.01 = 1, 2, 5


Leave blank if 6.1.10 = 2, 9

6.1.12

Completeness of polyp removal (from colonoscopy)


Were all the polyps completely removed during 1st test if it was a colonoscopy?

1

198

198

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 6.1.01 = 1, 2, 3, 5

6.1.13

Recommended next follow-up procedure within this cycle after 1st test


The next follow-up procedure recommended to the client (within the cycle). This can be a diagnostic follow-up test following a positive initial test, or surgery to complete diagnosis.

1

199

199

1 = Sigmoidoscopy

2 = Colonoscopy

3 = DCBE

4 = Surgery to complete diagnosis*

8 = None (cycle is complete)



* Diagnosis Information for Surgeries Performed to Complete Diagnosis section must be completed if surgery is recommended.

Range check.


If response = 4 or 8, then 6.2.01, 6.3.01 and 6.4.01 should = 0 (None).

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

6.2.01

2nd test provided within this cycle


The actual second test provided through the program.


Provided = Paid For”

1

200

200

0 = None

3 = Sigmoidoscopy

4 = Colonoscopy

5 = DCBE


NOTE: FOBT/FIT can not be a second, third or fourth test in a “cycle”.

Range check.


If response = 0 (None), then 6.2.02 through 6.2.13 should be blank.

6.2.02

Date of 2nd test


The date of the procedure.

8

201

208

MMDDYYYY


If just the year is known, blank fill the month and day. If just the year and month are known, blank fill the day (e.g. 04 2006).

MMDDYYYY”, “MM YYYY” or “YYYY”, but not blank.

6.2.03

Provider specialty


The specialty of the clinician providing the 2nd test.

2

209

210

1 = General practitioner

2 = Internist

3 = Family practitioner

4 = Gastroenterologist

5 = General surgeon

6 = Colorectal surgeon

7 = Licensed practical nurse

8 = Registered nurse

9 = Nurse practitioner

10 = Physician assistant

99 = Unknown


Right justify

Range check.

6.2.04

Clinical practice site


The type of clinical practice where the 2nd test was provided.

1

211

211

1 = Doctor’s office

2 = Ambulatory endoscopy/surgery center

3 = Hospital

4 = Health clinic

9 = Unknown

Range check.

6.2.05

(Item not used for 2nd test in “cycle”)






6.2.06

Results of endoscopy or DCBE


This question is answered if 6.2.01 was a colonoscopy, a sigmoidoscopy or a DCBE.

1

212

212

1 = Normal/negative/diverticulosis/hemorrhoids

2 = Other finding not suggestive of cancer/polyp(s)

3 = Polyp(s)/suspicious for cancer/presumed cancer

4 = No findings/inconclusive

5 = Pending

9 = Unknown


NOTE: If more than one result, report the worst.

Range check.



6.2.07

Was the bowel preparation considered adequate by the clinician performing the endoscopy or DCBE?


This question is answered if 6.2.01 was a colonoscopy, a sigmoidoscopy or a DCBE.


1

213

213

1 = Yes*

2 = No

9 = Unknown



Adequacy will be determined by the clinician performing the test.


*Procedure report must explicitly state that the bowel prep was adequate, otherwise report 9 (Unknown).

Range check.



6.2.08

Was the cecum reached during the initial colonoscopy?


This question is answered if 6.2.01 was a colonoscopy.

1

214

214

1 = Yes*

2 = No

9 = Unknown


*Procedure report must explicitly state that the cecum was reached, otherwise report 9 (Unknown).

Range check.


Leave blank if 6.2.01 = 3, 5

6.2.09

Complications of endoscopy or DCBE


This question is answered if 6.2.01 was a colonoscopy, a sigmoidoscopy or a DCBE.

1

215

215

1 = Yes

2 = No/unknown

Range check.



6.2.10

Was a biopsy/polypectomy performed during the endoscopy?


This question is answered if 6.2.01 was a colonoscopy or a sigmoidoscopy.

1

216

216

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 6.2.01 = 5

6.2.11

Number of specimens sent to pathology (from endoscopy)


This question is answered if 6.2.01 was a colonoscopy or a sigmoidoscopy, and a biopsy/polypectomy was performed.


Includes samples removed entirely or in part. If a single polyp is removed piecemeal you would report the number of specimens (not the number of polyps).

2

217

218

0 = Biopsy performed, no specimens sent

1 - 97 = Number of specimens

98 = ≥ 98 specimens

99 = Unknown



Right justify

Range check.


Leave blank if 6.2.01 = 5


Leave blank if 6.2.10 = 2, 9

6.2.12

Completeness of polyp removal (from colonoscopy)


Were all the polyps completely removed during 2nd test if it was a colonoscopy?

1

219

219

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 6.2.01 = 3, 5

6.2.13

Recommended next follow-up procedure within this cycle after 2nd test.


The next follow-up procedure recommended to the client (within the cycle). This can be another diagnostic follow-up test or surgery to complete diagnosis.

1

220

220

1 = Sigmoidoscopy

2 = Colonoscopy

3 = DCBE

4 = Surgery to complete diagnosis*

8 = None (cycle is complete)



* Diagnosis Information for Surgeries Performed to Complete Diagnosis section must be completed if surgery is recommended.

Range check.


If response = 4 or 8, then 6.3.01 and 6.4.01 should = 0 (None).

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

6.3.01

3rd test provided within this cycle


The actual third test provided through the program.


Provided = Paid For"

1

221

221

0 = None

3 = Sigmoidoscopy

4 = Colonoscopy

5 = DCBE


NOTE: FOBT/FIT can not be a second, third or fourth test in a “cycle”.

Range check.


If response = 0 (None), then 6.3.02 through 6.3.13 should be blank.

6.3.02

Date of 3rd test


The date of the procedure.

8

222

229

MMDDYYYY


If just the year is known, blank fill the month and day. If just the year and month are known, blank fill the day (e.g. 04 2006).

MMDDYYYY”, “MM YYYY” or “YYYY”, but not blank.

6.3.03

Provider specialty


The specialty of the clinician providing the 3rd test.

2

230

231

1 = General practitioner

2 = Internist

3 = Family practitioner

4 = Gastroenterologist

5 = General surgeon

6 = Colorectal surgeon

7 = Licensed practical nurse

8 = Registered nurse

9 = Nurse practitioner

10 = Physician assistant

99 = Unknown


Right justify

Range check.

6.3.04

Clinical practice site


The type of clinical practice where the 3rd test was provided.

1

232

232

1 = Doctor’s office

2 = Ambulatory endoscopy/surgery center

3 = Hospital

4 = Health clinic

9 = Unknown

Range check.

6.3.05

(Item not used for 3rd test in “cycle”)






6.3.06

Results of endoscopy or DCBE


This question is answered if 6.3.01 was a colonoscopy, a sigmoidoscopy or a DCBE.

1

233

233

1 = Normal/negative/diverticulosis/hemorrhoids

2 = Other finding not suggestive of cancer/polyp(s)

3 = Polyp(s)/suspicious for cancer/presumed cancer

4 = No findings/inconclusive

5 = Pending

9 = Unknown


NOTE: If more than one result, report the worst.

Range check.



6.3.07

Was the bowel preparation considered adequate by the clinician performing the endoscopy or DCBE?


This question is answered if 6.3.01 was a colonoscopy, a sigmoidoscopy or a DCBE.


1

234

234

1 = Yes*

2 = No

9 = Unknown



Adequacy will be determined by the clinician performing the test.


*Procedure report must explicitly state that the bowel prep was adequate, otherwise report 9 (Unknown).

Range check.



6.3.08

Was the cecum reached during the initial colonoscopy?


This question is answered if 6.3.01 was a colonoscopy.

1

235

235

1 = Yes*

2 = No

9 = Unknown


*Procedure report must explicitly state that the cecum was reached, otherwise report 9 (Unknown).

Range check.


Leave blank if 6.3.0 1 = 3, 5

6.3.09

Complications of endoscopy or DCBE


This question is answered if 6.3.01 was a colonoscopy, a sigmoidoscopy or a DCBE.

1

236

236

1 = Yes

2 = No/unknown

Range check.



6.3.10

Was a biopsy/polypectomy performed during the endoscopy?


This question is answered if 6.3.01 was a colonoscopy or a sigmoidoscopy.

1

237

237

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 6.3.01 = 5

6.3.11

Number of specimens sent to pathology (from endoscopy)


This question is answered if 6.3.01 was a colonoscopy or a sigmoidoscopy, and a biopsy/polypectomy was performed.


Includes samples removed entirely or in part. If a single polyp is removed piecemeal you would report the number of specimens (not the number of polyps).

2

238

239

0 = Biopsy performed, no specimens sent

1 - 97 = Number of specimens

98 = ≥ 98 specimens

99 = Unknown



Right justify

Range check.


Leave blank if 6.3.01 = 5


Leave blank if 6.3.10 = 2, 9

6.3.12

Completeness of polyp removal (from colonoscopy)


Were all the polyps completely removed during 3rd test if it was a colonoscopy?

1

240

240

1 = Yes

2 = No

9 = Unknown

Range check.

Leave blank if 6.3.01 = 3, 5

6.3.13

Recommended next follow-up procedure within this cycle after 3rd test.


The next follow-up procedure recommended to the client (within the cycle). This can be another diagnostic follow-up test or surgery to complete diagnosis.

1

241

241

1 = Sigmoidoscopy

2 = Colonoscopy

3 = DCBE

4 = Surgery to complete diagnosis*

8 = None (cycle is complete)



* Diagnosis Information for Surgeries Performed to Complete Diagnosis section must be completed if surgery is recommended.

Range check.


If response = 4 or 8, then 6.4.01 should = 0 (None).

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

6.4.01

4th test provided within this cycle


The actual fourth test provided through the program.


Provided = Paid For”.

1

242

242

0 = None

3 = Sigmoidoscopy

4 = Colonoscopy

5 = DCBE


NOTE: FOBT/FIT can not be a second, third or fourth test in a “cycle”.

Range check.


If response = 0 (None), then 6.4.02 through 6.4.13 should be blank.

6.4.02

Date of 4th test


The date of the procedure.

8

243

250

MMDDYYYY


If just the year is known, blank fill the month and day. If just the year and month are known, blank fill the day (e.g. 04 2006).

MMDDYYYY”, “MM YYYY” or “YYYY”, but not blank.

6.4.03

Provider specialty


The specialty of the clinician providing the 4th test.

2

251

252

1 = General practitioner

2 = Internist

3 = Family practitioner

4 = Gastroenterologist

5 = General surgeon

6 = Colorectal surgeon

7 = Licensed practical nurse

8 = Registered nurse

9 = Nurse practitioner

10 = Physician assistant

99 = Unknown


Right justify

Range check.

6.4.04

Clinical practice site


The type of clinical practice where the 4th test was provided.

1

253

253

1 = Doctor’s office

2 = Ambulatory endoscopy/surgery center

3 = Hospital

4 = Health clinic

9 = Unknown

Range check.

6.4.05

(Item not used for 4th test in “cycle”)






6.4.06

Results of endoscopy or DCBE


This question is answered if 6.4.01 was a colonoscopy, a sigmoidoscopy or a DCBE.

1

254

254

1 = Normal/negative/diverticulosis/hemorrhoids

2 = Other finding not suggestive of cancer/polyp(s)

3 = Polyp(s)/suspicious for cancer/presumed cancer

4 = No findings/inconclusive

5 = Pending

9 = Unknown


NOTE: If more than one result, report the worst.

Range check.



6.4.07

Was the bowel preparation considered adequate by the clinician performing the endoscopy or DCBE?


This question is answered if 6.4.01 was a colonoscopy, a sigmoidoscopy or a DCBE.


1

255

255

1 = Yes*

2 = No

9 = Unknown



Adequacy will be determined by the clinician performing the test.


*Procedure report must explicitly state that the bowel prep was adequate, otherwise report 9 (Unknown).

Range check.



6.4.08

Was the cecum reached during the initial colonoscopy?


This question is answered if 6.4.01 was a colonoscopy.

1

256

256

1 = Yes*

2 = No

9 = Unknown


*Procedure report must explicitly state that the cecum was reached, otherwise report 9 (Unknown).

Range check.


Leave blank if 6.4.01 = 3, 5

6.4.09

Complications of endoscopy or DCBE


This question is answered if 6.4.01 was a colonoscopy, a sigmoidoscopy or a DCBE.

1

257

257

1 = Yes

2 = No/unknown

Range check.



6.4.10

Was a biopsy/polypectomy performed during the endoscopy?


This question is answered if 6.4.01 was a colonoscopy or a sigmoidoscopy.

1

258

258

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 6.4.01 = 5

6.4.11

Number of specimens sent to pathology (from endoscopy)


This question is answered if 6.4.01 was a colonoscopy or a sigmoidoscopy, and a biopsy/polypectomy was performed.


Includes samples removed entirely or in part. If a single polyp is removed piecemeal you would report the number of specimens (not the number of polyps).

2

259

260

0 = Biopsy performed, no specimens sent

1 - 97 = Number of specimens

98 = ≥ 98 specimens

99 = Unknown



Right justify

Range check.


Leave blank if 6.4.01 = 5


Leave blank if 6.4.10 = 2, 9

6.4.12

Completeness of polyp removal (from colonoscopy)


Were all the polyps completely removed during 4th test if it was a colonoscopy?

1

261

261

1 = Yes

2 = No

9 = Unknown




Range check.


Leave blank if 6.4.01 = 3, 5

6.4.13

Recommended next follow-up procedure after 4th test.


The next follow-up procedure recommended to the client. This can be another diagnostic follow-up test or surgery to complete diagnosis.

1

262

262

4 = Surgery to complete diagnosis*

8 = None (cycle is complete)



* Diagnosis Information for Surgeries Performed to Complete Diagnosis section must be completed if surgery is recommended.

Range check.



Reserved for future use

10

263

272


Leave blank.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

7. Diagnosis Information for All Polyps/Lesions – Complete for each CCDE record

7.0

Total number of polyps/lesions


Total number of unique polyps/lesions identified through all colonoscopies and/or sigmoidoscopies during the client’s “cycle”.

2

273

274

0 = No polyps

1 – 96 = Number of polyps

97 = ≥ 97 polyps

98 = At least one polyp, exact number not known

99 = Unknown


Specimens from surgical resections do not belong in this section.


Right justify

Range check.


7.01.1

Location of 1st polyp/lesion



NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps.



2

275

276

1 = Rectum

2 = Rectosigmoid junction

3 = Sigmoid

4 = Descending

5 = Splenic flexure

6 = Transverse

7 = Hepatic flexure

8 = Ascending

9 = Cecum

10 = Appendix

11 = Overlapping lesions

99 = Unknown


Location will generally be found on the endoscopy report.


Right justify

Range check.

Leave blank if 7.0 = 0

7.01.2

Size of 1st polyp/lesion


This is the diameter of the polyp/lesion in millimeters (mm) or the longest dimension of the polyp/lesion if asymmetric.


NOTE: This should be the size of the actual polyp and not the size of the biopsy specimen submitted for pathology.

2

277

278

0 = < 1 mm

1 – 97 = Size of polyp/lesion in mm

98 = ≥ 98 mm

99 = Unknown


Right justify


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps. Size may be found on both the endoscopy and pathology reports, but size from the endoscopy report is preferred. If the specimen is not intact when sent to the pathology lab do NOT report specimen size from the pathology report.

Range check.


Leave blank if 7.0 = 0

7.01.3.1

Procedure for removal of 1st polyp/lesion (1)


This is the first procedure performed during removal/biopsy of the polyp/lesion.

1

279

279

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.01.3.2

Procedure for removal of 1st polyp/lesion (2)


This is the second procedure performed during removal/biopsy of the polyp/lesion.



1

280

280

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than one procedure was performed during the polyp/lesion removal.

7.01.3.3

Procedure for removal of 1st polyp/lesion (3)


This is the third procedure performed during removal/biopsy of the polyp/lesion.


1

281

281

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than two procedures were performed during the polyp/lesion removal.

7.01.4

Was 1st polyp/lesion completely removed?

1

282

282

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.01.5

Histology of 1st polyp/lesion


This is the histology of the polyp/lesion. If polyp was submitted to pathology as piecemeal fragments and more than one histological diagnosis was reported, report the worst (the response options are listed in general order of severity).


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy and pathology reports in order to “match up” the correct lesions.

2

283

284

1 = Normal or other non-polyp histology

2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)

3 = Hyperplastic polyp

4 = Adenoma, NOS (no high grade dysplasia noted)

5 = Adenoma, tubular (no high grade dysplasia noted)

6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)

7 = Adenoma, villous (no high grade dysplasia noted)

8 = Adenoma, serrated (no high grade dysplasia noted)

9 = Adenoma with high grade dysplasia (includes in situ carcinoma)

10 = Adenocarcinoma, invasive

11 = Carcinoma, other

99 = Unknown/other lesions ablated, not retrieved or confirmed


Histologies for all polyps/lesions should be reviewed and a final diagnosis recorded in Item 9.2.


Right justify

Range check.


Leave blank if 7.0 = 0


Do not update/change this variable if polyp with high grade dysplasia is determined to be cancer during a subsequent surgery.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

7.02.1

Location of 2nd polyp/lesion


Complete only if more than one polyp/lesion was removed.


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps.



2

285

286

1 = Rectum

2 = Rectosigmoid junction

3 = Sigmoid

4 = Descending

5 = Splenic flexure

6 = Transverse

7 = Hepatic flexure

8 = Ascending

9 = Cecum

10 = Appendix

11 = Overlapping lesions

99 = Unknown


Location will generally be found on the endoscopy report.


Right justify

Range check.

Leave blank if 7.0 = 0

7.02.2

Size of 2nd polyp/lesion


This is the diameter of the polyp/lesion in millimeters (mm) or the longest dimension of the polyp/lesion if asymmetric.


NOTE: This should be the size of the actual polyp and not the size of the biopsy specimen submitted for pathology.

2

287

288

0 = < 1 mm

1 – 97 = Size of polyp/lesion in mm

98 = ≥ 98 mm

99 = Unknown


Right justify


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps. Size may be found on both the endoscopy and pathology reports, but size from the endoscopy report is preferred. If the specimen is not intact when sent to the pathology lab do NOT report specimen size from the pathology report.

Range check.


Leave blank if 7.0 = 0

7.02.3.1

Procedure for removal of 2nd polyp/lesion (1)


This is the first procedure performed during removal/biopsy of the polyp/lesion.

1

289

289

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.02.3.2

Procedure for removal of 2nd polyp/lesion (2)


This is the second procedure performed during removal/biopsy of the polyp/lesion.



1

290

290

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than one procedure was performed during the polyp/lesion removal.

7.02.3.3

Procedure for removal of 2nd polyp/lesion (3)


This is the third procedure performed during removal/biopsy of the polyp/lesion.

1

291

291

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than two procedures were performed during the polyp/lesion removal.

7.02.4

Was 2nd polyp/lesion completely removed?

1

292

292

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.02.5

Histology of 2nd polyp/lesion


This is the histology of the polyp/lesion. If polyp was submitted to pathology as piecemeal fragments and more than one histological diagnosis was reported, report the worst (the response options are listed in general order of severity).


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy and pathology reports in order to “match up” the correct lesions.

2

293

294

1 = Normal or other non-polyp histology

2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)

3 = Hyperplastic polyp

4 = Adenoma, NOS (no high grade dysplasia noted)

5 = Adenoma, tubular (no high grade dysplasia noted)

6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)

7 = Adenoma, villous (no high grade dysplasia noted)

8 = Adenoma, serrated (no high grade dysplasia noted)

9 = Adenoma with high grade dysplasia (includes in situ carcinoma)

10 = Adenocarcinoma, invasive

11 = Carcinoma, other

99 = Unknown/other lesions ablated, not retrieved or confirmed


Histologies for all polyps/lesions should be reviewed and a final diagnosis recorded in Item 9.2.


Right justify

Range check.


Leave blank if 7.0 = 0


Do not update/change this variable if polyp with high grade dysplasia is determined to be cancer during a subsequent surgery.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

7.03.1

Location of 3rd polyp/lesion


Complete only if more than two polyps/lesions were removed.


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps.



2

295

296

1 = Rectum

2 = Rectosigmoid junction

3 = Sigmoid

4 = Descending

5 = Splenic flexure

6 = Transverse

7 = Hepatic flexure

8 = Ascending

9 = Cecum

10 = Appendix

11 = Overlapping lesions

99 = Unknown


Location will generally be found on the endoscopy report.


Right justify

Range check.

Leave blank if 7.0 = 0

7.03.2

Size of 3rd polyp/lesion


This is the diameter of the polyp/lesion in millimeters (mm) or the longest dimension of the polyp/lesion if asymmetric.


NOTE: This should be the size of the actual polyp and not the size of the biopsy specimen submitted for pathology.

2

297

298

0 = < 1 mm

1 – 97 = Size of polyp/lesion in mm

98 = ≥ 98 mm

99 = Unknown


Right justify


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps. Size may be found on both the endoscopy and pathology reports, but size from the endoscopy report is preferred. If the specimen is not intact when sent to the pathology lab do NOT report specimen size from the pathology report.

Range check.


Leave blank if 7.0 = 0

7.03.3.1

Procedure for removal of 3rd polyp/lesion (1)


This is the first procedure performed during removal/biopsy of the polyp/lesion.

1

299

299

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.03.3.2

Procedure for removal of 3rd polyp/lesion (2)


This is the second procedure performed during removal/biopsy of the polyp/lesion.



1

300

300

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than one procedure was performed during the polyp/lesion removal.

7.03.3.3

Procedure for removal of 3rd polyp/lesion (3)


This is the third procedure performed during removal/biopsy of the polyp/lesion.

1

301

301

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than two procedures were performed during the polyp/lesion removal.

7.03.4

Was 3rd polyp/lesion completely removed?

1

302

302

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.03.5

Histology of 3rd polyp/lesion


This is the histology of the polyp/lesion. If polyp was submitted to pathology as piecemeal fragments and more than one histological diagnosis was reported, report the worst (the response options are listed in general order of severity).


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy and pathology reports in order to “match up” the correct lesions.

2

303

304

1 = Normal or other non-polyp histology

2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)

3 = Hyperplastic polyp

4 = Adenoma, NOS (no high grade dysplasia noted)

5 = Adenoma, tubular (no high grade dysplasia noted)

6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)

7 = Adenoma, villous (no high grade dysplasia noted)

8 = Adenoma, serrated (no high grade dysplasia noted)

9 = Adenoma with high grade dysplasia (includes in situ carcinoma)

10 = Adenocarcinoma, invasive

11 = Carcinoma, other

99 = Unknown/other lesions ablated, not retrieved or confirmed


Histologies for all polyps/lesions should be reviewed and a final diagnosis recorded in Item 9.2.


Right justify

Range check.


Leave blank if 7.0 = 0


Do not update/change this variable if polyp with high grade dysplasia is determined to be cancer during a subsequent surgery.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

7.04.1

Location of 4th polyp/lesion


Complete only if more than three polyps/lesions were removed.


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps.


2

305

306

1 = Rectum

2 = Rectosigmoid junction

3 = Sigmoid

4 = Descending

5 = Splenic flexure

6 = Transverse

7 = Hepatic flexure

8 = Ascending

9 = Cecum

10 = Appendix

11 = Overlapping lesions

99 = Unknown


Location will generally be found on the endoscopy report.


Right justify

Range check.

Leave blank if 7.0 = 0

7.04.2

Size of 4th polyp/lesion


This is the diameter of the polyp/lesion in millimeters (mm) or the longest dimension of the polyp/lesion if asymmetric.


NOTE: This should be the size of the actual polyp and not the size of the biopsy specimen submitted for pathology.

2

307

308

0 = < 1 mm

1 – 97 = Size of polyp/lesion in mm

98 = ≥ 98 mm

99 = Unknown


Right justify


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps. Size may be found on both the endoscopy and pathology reports, but size from the endoscopy report is preferred. If the specimen is not intact when sent to the pathology lab do NOT report specimen size from the pathology report.

Range check.


Leave blank if 7.0 = 0

7.04.3.1

Procedure for removal of 4th polyp/lesion (1)


This is the first procedure performed during removal/biopsy of the polyp/lesion.

1

309

309

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.04.3.2

Procedure for removal of 4th polyp/lesion (2)


This is the second procedure performed during removal/biopsy of the polyp/lesion.


1

310

310

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than one procedure was performed during the polyp/lesion removal.

7.04.3.3

Procedure for removal of 4th polyp/lesion (3)


This is the third procedure performed during removal/biopsy of the polyp/lesion.

1

311

311

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than two procedures were performed during the polyp/lesion removal.

7.04.4

Was 4th polyp/lesion completely removed?

1

312

312

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.04.5

Histology of 4th polyp/lesion


This is the histology of the polyp/lesion. If polyp was submitted to pathology as piecemeal fragments and more than one histological diagnosis was reported, report the worst (the response options are listed in general order of severity).


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy and pathology reports in order to “match up” the correct lesions.

2

313

314

1 = Normal or other non-polyp histology

2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)

3 = Hyperplastic polyp

4 = Adenoma, NOS (no high grade dysplasia noted)

5 = Adenoma, tubular (no high grade dysplasia noted)

6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)

7 = Adenoma, villous (no high grade dysplasia noted)

8 = Adenoma, serrated (no high grade dysplasia noted)

9 = Adenoma with high grade dysplasia (includes in situ carcinoma)

10 = Adenocarcinoma, invasive

11 = Carcinoma, other

99 = Unknown/other lesions ablated, not retrieved or confirmed


Histologies for all polyps/lesions should be reviewed and a final diagnosis recorded in Item 9.2.


Right justify

Range check.


Leave blank if 7.0 = 0


Do not update/change this variable if polyp with high grade dysplasia is determined to be cancer during a subsequent surgery.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

7.05.1

Location of 5th polyp/lesion


Complete only if more than four polyps/lesions were removed.


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps.


Location will generally be found on the endoscopy report.

2

315

316

1 = Rectum

2 = Rectosigmoid junction

3 = Sigmoid

4 = Descending

5 = Splenic flexure

6 = Transverse

7 = Hepatic flexure

8 = Ascending

9 = Cecum

10 = Appendix

11 = Overlapping lesions

99 = Unknown


Right justify

Range check.

Leave blank if 7.0 = 0

7.05.2

Size of 5th polyp/lesion


This is the diameter of the polyp/lesion in millimeters (mm) or the longest dimension of the polyp/lesion if asymmetric.


NOTE: This should be the size of the actual polyp and not the size of the biopsy specimen submitted for pathology.

2

317

318

0 = < 1 mm

1 – 97 = Size of polyp/lesion in mm

98 = ≥ 98 mm

99 = Unknown


Right justify


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps. Size may be found on both the endoscopy and pathology reports, but size from the endoscopy report is preferred. If the specimen is not intact when sent to the pathology lab do NOT report specimen size from the pathology report.

Range check.


Leave blank if 7.0 = 0

7.05.3.1

Procedure for removal of 5th polyp/lesion (1)


This is the first procedure performed during removal/biopsy of the polyp/lesion.

1

319

319

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.05.3.2

Procedure for removal of 5th polyp/lesion (2)


This is the second procedure performed during removal/biopsy of the polyp/lesion.


1

320

320

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than one procedure was performed during the polyp/lesion removal.

7.05.3.3

Procedure for removal of 5th polyp/lesion (3)


This is the third procedure performed during removal/biopsy of the polyp/lesion.

1

321

321

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than two procedures were performed during the polyp/lesion removal.

7.05.4

Was 5th polyp/lesion completely removed?

1

322

322

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.05.5

Histology of 5th polyp/lesion


This is the histology of the polyp/lesion. If polyp was submitted to pathology as piecemeal fragments and more than one histological diagnosis was reported, report the worst (the response options are listed in general order of severity).


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy and pathology reports in order to “match up” the correct lesions.

2

323

324

1 = Normal or other non-polyp histology

2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)

3 = Hyperplastic polyp

4 = Adenoma, NOS (no high grade dysplasia noted)

5 = Adenoma, tubular (no high grade dysplasia noted)

6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)

7 = Adenoma, villous (no high grade dysplasia noted)

8 = Adenoma, serrated (no high grade dysplasia noted)

9 = Adenoma with high grade dysplasia (includes in situ carcinoma)

10 = Adenocarcinoma, invasive

11 = Carcinoma, other

99 = Unknown/other lesions ablated, not retrieved or confirmed


Histologies for all polyps/lesions should be reviewed and a final diagnosis recorded in Item 9.2.


Right justify

Range check.


Leave blank if 7.0 = 0


Do not update/change this variable if polyp with high grade dysplasia is determined to be cancer during a subsequent surgery.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

7.06.1

Location of 6th polyp/lesion


Complete only if more than five polyps/lesions were removed.


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps.


2

325

326

1 = Rectum

2 = Rectosigmoid junction

3 = Sigmoid

4 = Descending

5 = Splenic flexure

6 = Transverse

7 = Hepatic flexure

8 = Ascending

9 = Cecum

10 = Appendix

11 = Overlapping lesions

99 = Unknown


Location will generally be found on the endoscopy report.


Right justify

Range check.

Leave blank if 7.0 = 0

7.06.2

Size of 6th polyp/lesion


This is the diameter of the polyp/lesion in millimeters (mm) or the longest dimension of the polyp/lesion if asymmetric.


NOTE: This should be the size of the actual polyp and not the size of the biopsy specimen submitted for pathology.

2

327

328

0 = < 1 mm

1 – 97 = Size of polyp/lesion in mm

98 = ≥ 98 mm

99 = Unknown


Right justify


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps. Size may be found on both the endoscopy and pathology reports, but size from the endoscopy report is preferred. If the specimen is not intact when sent to the pathology lab do NOT report specimen size from the pathology report.

Range check.


Leave blank if 7.0 = 0

7.06.3.1

Procedure for removal of 6th polyp/lesion (1)


This is the first procedure performed during removal/biopsy of the polyp/lesion.

1

329

329

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.06.3.2

Procedure for removal of 6th polyp/lesion (2)


This is the second procedure performed during removal/biopsy of the polyp/lesion.


1

330

330

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than one procedure was performed during the polyp/lesion removal.

7.06.3.3

Procedure for removal of 6th polyp/lesion (3)


This is the third procedure performed during removal/biopsy of the polyp/lesion.

1

331

331

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than two procedures were performed during the polyp/lesion removal.

7.06.4

Was 6th polyp/lesion completely removed?

1

332

332

1 = Yes

2 = No

9 = Unknown

Range check. Leave blank if 7.0 = 0

7.06.5

Histology of 6th polyp/lesion


This is the histology of the polyp/lesion. If polyp was submitted to pathology as piecemeal fragments and more than one histological diagnosis was reported, report the worst (the response options are listed in general order of severity).


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy and pathology reports in order to “match up” the correct lesions.

2

333

334

1 = Normal or other non-polyp histology

2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)

3 = Hyperplastic polyp

4 = Adenoma, NOS (no high grade dysplasia noted)

5 = Adenoma, tubular (no high grade dysplasia noted)

6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)

7 = Adenoma, villous (no high grade dysplasia noted)

8 = Adenoma, serrated (no high grade dysplasia noted)

9 = Adenoma with high grade dysplasia (includes in situ carcinoma)

10 = Adenocarcinoma, invasive

11 = Carcinoma, other

99 = Unknown/other lesions ablated, not retrieved or confirmed


Histologies for all polyps/lesions should be reviewed and a final diagnosis recorded in Item 9.2.


Right justify

Range check.


Leave blank if 7.0 = 0


Do not update/change this variable if polyp with high grade dysplasia is determined to be cancer during a subsequent surgery.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

7.07.1

Location of 7th polyp/lesion


Complete only if more than six polyps/lesions were removed.


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps.


2

335

336

1 = Rectum

2 = Rectosigmoid junction

3 = Sigmoid

4 = Descending

5 = Splenic flexure

6 = Transverse

7 = Hepatic flexure

8 = Ascending

9 = Cecum

10 = Appendix

11 = Overlapping lesions

99 = Unknown


Location will generally be found on the endoscopy report.


Right justify

Range check.

Leave blank if 7.0 = 0

7.07.2

Size of 7th polyp/lesion


This is the diameter of the polyp/lesion in millimeters (mm) or the longest dimension of the polyp/lesion if asymmetric.


NOTE: This should be the size of the actual polyp and not the size of the biopsy specimen submitted for pathology.

2

337

338

0 = < 1 mm

1 – 97 = Size of polyp/lesion in mm

98 = ≥ 98 mm

99 = Unknown


Right justify


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps. Size may be found on both the endoscopy and pathology reports, but size from the endoscopy report is preferred. If the specimen is not intact when sent to the pathology lab do NOT report specimen size from the pathology report.

Range check.


Leave blank if 7.0 = 0

7.07.3.1

Procedure for removal of 7th polyp/lesion (1)


This is the first procedure performed during removal/biopsy of the polyp/lesion.

1

339

339

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.07.3.2

Procedure for removal of 7th polyp/lesion (2)


This is the second procedure performed during removal/biopsy of the polyp/lesion.



1

340

340

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than one procedure was performed during the polyp/lesion removal.

7.07.3.3

Procedure for removal of 7th polyp/lesion (3)


This is the third procedure performed during removal/biopsy of the polyp/lesion.

1

341

341

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than two procedures were performed during the polyp/lesion removal.

7.07.4

Was 7th polyp/lesion completely removed?

1

342

342

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.07.5

Histology of 7th polyp/lesion


This is the histology of the polyp/lesion. If polyp was submitted to pathology as piecemeal fragments and more than one histological diagnosis was reported, report the worst (the response options are listed in general order of severity).


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy and pathology reports in order to “match up” the correct lesions.

2

343

344

1 = Normal or other non-polyp histology

2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)

3 = Hyperplastic polyp

4 = Adenoma, NOS (no high grade dysplasia noted)

5 = Adenoma, tubular (no high grade dysplasia noted)

6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)

7 = Adenoma, villous (no high grade dysplasia noted)

8 = Adenoma, serrated (no high grade dysplasia noted)

9 = Adenoma with high grade dysplasia (includes in situ carcinoma)

10 = Adenocarcinoma, invasive

11 = Carcinoma, other

99 = Unknown/other lesions ablated, not retrieved or confirmed


Histologies for all polyps/lesions should be reviewed and a final diagnosis recorded in Item 9.2.


Right justify

Range check.


Leave blank if 7.0 = 0


Do not update/change this variable if polyp with high grade dysplasia is determined to be cancer during a subsequent surgery.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

7.08.1

Location of 8th polyp/lesion


Complete only if more than seven polyps/lesions were removed.


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps.


2

345

346

1 = Rectum

2 = Rectosigmoid junction

3 = Sigmoid

4 = Descending

5 = Splenic flexure

6 = Transverse

7 = Hepatic flexure

8 = Ascending

9 = Cecum

10 = Appendix

11 = Overlapping lesions

99 = Unknown


Location will generally be found on the endoscopy report.


Right justify

Range check.

Leave blank if 7.0 = 0

7.08.2

Size of 8th polyp/lesion


This is the diameter of the polyp/lesion in millimeters (mm) or the longest dimension of the polyp/lesion if asymmetric.


NOTE: This should be the size of the actual polyp and not the size of the biopsy specimen submitted for pathology.

2

347

348

0 = < 1 mm

1 – 97 = Size of polyp/lesion in mm

98 = ≥ 98 mm

99 = Unknown


Right justify


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps. Size may be found on both the endoscopy and pathology reports, but size from the endoscopy report is preferred. If the specimen is not intact when sent to the pathology lab do NOT report specimen size from the pathology report.

Range check.


Leave blank if 7.0 = 0

7.08.3.1

Procedure for removal of 8th polyp/lesion (1)


This is the first procedure performed during removal/biopsy of the polyp/lesion.

1

349

349

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.08.3.2

Procedure for removal of 8th polyp/lesion (2)


This is the second procedure performed during removal/biopsy of the polyp/lesion.


1

350

350

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than one procedure was performed during the polyp/lesion removal.

7.08.3.3

Procedure for removal of 8th polyp/lesion (3)


This is the third procedure performed during removal/biopsy of the polyp/lesion.

1

351

351

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than two procedures were performed during the polyp/lesion removal.

7.08.4

Was 8th polyp/lesion completely removed?

1

352

352

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.08.5

Histology of 8th polyp/lesion


This is the histology of the polyp/lesion. If polyp was submitted to pathology as piecemeal fragments and more than one histological diagnosis was reported, report the worst (the response options are listed in general order of severity).


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy and pathology reports in order to “match up” the correct lesions.

2

353

354

1 = Normal or other non-polyp histology

2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)

3 = Hyperplastic polyp

4 = Adenoma, NOS (no high grade dysplasia noted)

5 = Adenoma, tubular (no high grade dysplasia noted)

6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)

7 = Adenoma, villous (no high grade dysplasia noted)

8 = Adenoma, serrated (no high grade dysplasia noted)

9 = Adenoma with high grade dysplasia (includes in situ carcinoma)

10 = Adenocarcinoma, invasive

11 = Carcinoma, other

99 = Unknown/other lesions ablated, not retrieved or confirmed


Histologies for all polyps/lesions should be reviewed and a final diagnosis recorded in Item 9.2.


Right justify

Range check.


Leave blank if 7.0 = 0


Do not update/change this variable if polyp with high grade dysplasia is determined to be cancer during a subsequent surgery.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

7.09.1

Location of 9th polyp/lesion


Complete only if more than eight polyps/lesions were removed.


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps.


2

355

356

1 = Rectum

2 = Rectosigmoid junction

3 = Sigmoid

4 = Descending

5 = Splenic flexure

6 = Transverse

7 = Hepatic flexure

8 = Ascending

9 = Cecum

10 = Appendix

11 = Overlapping lesions

99 = Unknown


Location will generally be found on the endoscopy report.


Right justify

Range check.

Leave blank if 7.0 = 0

7.09.2

Size of 9th polyp/lesion


This is the diameter of the polyp/lesion in millimeters (mm) or the longest dimension of the polyp/lesion if asymmetric.


NOTE: This should be the size of the actual polyp and not the size of the biopsy specimen submitted for pathology.

2

357

358

0 = < 1 mm

1 – 97 = Size of polyp/lesion in mm

98 = ≥ 98 mm

99 = Unknown


Right justify


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps. Size may be found on both the endoscopy and pathology reports, but size from the endoscopy report is preferred. If the specimen is not intact when sent to the pathology lab do NOT report specimen size from the pathology report.

Range check.


Leave blank if 7.0 = 0

7.09.3.1

Procedure for removal of 9th polyp/lesion (1)


This is the first procedure performed during removal/biopsy of the polyp/lesion.

1

359

359

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.09.3.2

Procedure for removal of 9th polyp/lesion (2)


This is the second procedure performed during removal/biopsy of the polyp/lesion.


1

360

360

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than one procedure was performed during the polyp/lesion removal.

7.09.3.3

Procedure for removal of 9th polyp/lesion (3)


This is the third procedure performed during removal/biopsy of the polyp/lesion.

1

361

361

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than two procedures were performed during the polyp/lesion removal.

7.09.4

Was 9th polyp/lesion completely removed?

1

362

362

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.09.5

Histology of 9th polyp/lesion


This is the histology of the polyp/lesion. If polyp was submitted to pathology as piecemeal fragments and more than one histological diagnosis was reported, report the worst (the response options are listed in general order of severity).


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy and pathology reports in order to “match up” the correct lesions.

2

363

364

1 = Normal or other non-polyp histology

2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)

3 = Hyperplastic polyp

4 = Adenoma, NOS (no high grade dysplasia noted)

5 = Adenoma, tubular (no high grade dysplasia noted)

6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)

7 = Adenoma, villous (no high grade dysplasia noted)

8 = Adenoma, serrated (no high grade dysplasia noted)

9 = Adenoma with high grade dysplasia (includes in situ carcinoma)

10 = Adenocarcinoma, invasive

11 = Carcinoma, other

99 = Unknown/other lesions ablated, not retrieved or confirmed


Histologies for all polyps/lesions should be reviewed and a final diagnosis recorded in Item 9.2.


Right justify

Range check.


Leave blank if 7.0 = 0


Do not update/change this variable if polyp with high grade dysplasia is determined to be cancer during a subsequent surgery.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

7.10.1

Location of 10th polyp/lesion


Complete only if more than nine polyps/lesions were removed.


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps.


2

365

366

1 = Rectum

2 = Rectosigmoid junction

3 = Sigmoid

4 = Descending

5 = Splenic flexure

6 = Transverse

7 = Hepatic flexure

8 = Ascending

9 = Cecum

10 = Appendix

11 = Overlapping lesions

99 = Unknown


Location will generally be found on the endoscopy report.


Right justify

Range check.

Leave blank if 7.0 = 0

7.10.2

Size of 10th polyp/lesion


This is the diameter of the polyp/lesion in millimeters (mm) or the longest dimension of the polyp/lesion if asymmetric.


NOTE: This should be the size of the actual polyp and not the size of the biopsy specimen submitted for pathology.

2

367

368

0 = < 1 mm

1 – 97 = Size of polyp/lesion in mm

98 = ≥ 98 mm

99 = Unknown


Right justify


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps. Size may be found on both the endoscopy and pathology reports, but size from the endoscopy report is preferred. If the specimen is not intact when sent to the pathology lab do NOT report specimen size from the pathology report.

Range check.


Leave blank if 7.0 = 0

7.10.3.1

Procedure for removal of 10th polyp/lesion (1)


This is the first procedure performed during removal/biopsy of the polyp/lesion.

1

369

369

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.10.3.2

Procedure for removal of 10th polyp/lesion (2)


This is the second procedure performed during removal/biopsy of the polyp/lesion.


1

370

370

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than one procedure was performed during the polyp/lesion removal.

7.10.3.3

Procedure for removal of 10th polyp/lesion (3)


This is the third procedure performed during removal/biopsy of the polyp/lesion.

1

371

371

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than two procedures were performed during the polyp/lesion removal.

7.10.4

Was 10th polyp/lesion completely removed?

1

372

372

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.10.5

Histology of 10th polyp/lesion


This is the histology of the polyp/lesion. If polyp was submitted to pathology as piecemeal fragments and more than one histological diagnosis was reported, report the worst (the response options are listed in general order of severity).


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy and pathology reports in order to “match up” the correct lesions.

2

373

374

1 = Normal or other non-polyp histology

2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)

3 = Hyperplastic polyp

4 = Adenoma, NOS (no high grade dysplasia noted)

5 = Adenoma, tubular (no high grade dysplasia noted)

6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)

7 = Adenoma, villous (no high grade dysplasia noted)

8 = Adenoma, serrated (no high grade dysplasia noted)

9 = Adenoma with high grade dysplasia (includes in situ carcinoma)

10 = Adenocarcinoma, invasive

11 = Carcinoma, other

99 = Unknown/other lesions ablated, not retrieved or confirmed


Histologies for all polyps/lesions should be reviewed and a final diagnosis recorded in Item 9.2.


Right justify

Range check.


Leave blank if 7.0 = 0


Do not update/change this variable if polyp with high grade dysplasia is determined to be cancer during a subsequent surgery.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

7.11.1

Location of 11th polyp/lesion


Complete only if more than ten polyps/lesions were removed.


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps.


2

375

376

1 = Rectum

2 = Rectosigmoid junction

3 = Sigmoid

4 = Descending

5 = Splenic flexure

6 = Transverse

7 = Hepatic flexure

8 = Ascending

9 = Cecum

10 = Appendix

11 = Overlapping lesions

99 = Unknown


Location will generally be found on the endoscopy report.


Right justify

Range check.

Leave blank if 7.0 = 0

7.11.2

Size of 11th polyp/lesion


This is the diameter of the polyp/lesion in millimeters (mm) or the longest dimension of the polyp/lesion if asymmetric.


NOTE: This should be the size of the actual polyp and not the size of the biopsy specimen submitted for pathology.

2

377

378

0 = < 1 mm

1 – 97 = Size of polyp/lesion in mm

98 = ≥ 98 mm

99 = Unknown


Right justify


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps. Size may be found on both the endoscopy and pathology reports, but size from the endoscopy report is preferred. If the specimen is not intact when sent to the pathology lab do NOT report specimen size from the pathology report.

Range check.


Leave blank if 7.0 = 0

7.11.3.1

Procedure for removal of 11th polyp/lesion (1)


This is the first procedure performed during removal/biopsy of the polyp/lesion.

1

379

379

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.11.3.2

Procedure for removal of 11th polyp/lesion (2)


This is the second procedure performed during removal/biopsy of the polyp/lesion.


1

380

380

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than one procedure was performed during the polyp/lesion removal.

7.11.3.3

Procedure for removal of 11th polyp/lesion (3)


This is the third procedure performed during removal/biopsy of the polyp/lesion.

1

381

381

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than two procedures were performed during the polyp/lesion removal.

7.11.4

Was 11th polyp/lesion completely removed?

1

382

382

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.11.5

Histology of 11th polyp/lesion


This is the histology of the polyp/lesion. If polyp was submitted to pathology as piecemeal fragments and more than one histological diagnosis was reported, report the worst (the response options are listed in general order of severity).


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy and pathology reports in order to “match up” the correct lesions.

2

383

384

1 = Normal or other non-polyp histology

2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)

3 = Hyperplastic polyp

4 = Adenoma, NOS (no high grade dysplasia noted)

5 = Adenoma, tubular (no high grade dysplasia noted)

6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)

7 = Adenoma, villous (no high grade dysplasia noted)

8 = Adenoma, serrated (no high grade dysplasia noted)

9 = Adenoma with high grade dysplasia (includes in situ carcinoma)

10 = Adenocarcinoma, invasive

11 = Carcinoma, other

99 = Unknown/other lesions ablated, not retrieved or confirmed


Histologies for all polyps/lesions should be reviewed and a final diagnosis recorded in Item 9.2.


Right justify

Range check.


Leave blank if 7.0 = 0


Do not update/change this variable if polyp with high grade dysplasia is determined to be cancer during a subsequent surgery.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

7.12.1

Location of 12th polyp/lesion


Complete only if more than eleven

polyps/lesions were removed.


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps.


2

385

386

1 = Rectum

2 = Rectosigmoid junction

3 = Sigmoid

4 = Descending

5 = Splenic flexure

6 = Transverse

7 = Hepatic flexure

8 = Ascending

9 = Cecum

10 = Appendix

11 = Overlapping lesions

99 = Unknown


Location will generally be found on the endoscopy report.


Right justify

Range check.

Leave blank if 7.0 = 0

7.12.2

Size of 12th polyp/lesion


This is the diameter of the polyp/lesion in millimeters (mm) or the longest dimension of the polyp/lesion if asymmetric.


NOTE: This should be the size of the actual polyp and not the size of the biopsy specimen submitted for pathology.

2

387

388

0 = < 1 mm

1 – 97 = Size of polyp/lesion in mm

98 = ≥ 98 mm

99 = Unknown


Right justify


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps. Size may be found on both the endoscopy and pathology reports, but size from the endoscopy report is preferred. If the specimen is not intact when sent to the pathology lab do NOT report specimen size from the pathology report.

Range check.


Leave blank if 7.0 = 0

7.12.3.1

Procedure for removal of 12th polyp/lesion (1)


This is the first procedure performed during removal/biopsy of the polyp/lesion.

1

389

389

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.12.3.2

Procedure for removal of 12th polyp/lesion (2)


This is the second procedure performed during removal/biopsy of the polyp/lesion.



1

390

390

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than one procedure was performed during the polyp/lesion removal.

7.12.3.3

Procedure for removal of 12th polyp/lesion (3)


This is the third procedure performed during removal/biopsy of the polyp/lesion.

1

391

391

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than two procedures were performed during the polyp/lesion removal.

7.12.4

Was 12th polyp/lesion completely removed?

1

392

392

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.12.5

Histology of 12th polyp/lesion


This is the histology of the polyp/lesion. If polyp was submitted to pathology as piecemeal fragments and more than one histological diagnosis was reported, report the worst (the response options are listed in general order of severity).


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy and pathology reports in order to “match up” the correct lesions.

2

393

394

1 = Normal or other non-polyp histology

2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)

3 = Hyperplastic polyp

4 = Adenoma, NOS (no high grade dysplasia noted)

5 = Adenoma, tubular (no high grade dysplasia noted)

6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)

7 = Adenoma, villous (no high grade dysplasia noted)

8 = Adenoma, serrated (no high grade dysplasia noted)

9 = Adenoma with high grade dysplasia (includes in situ carcinoma)

10 = Adenocarcinoma, invasive

11 = Carcinoma, other

99 = Unknown/other lesions ablated, not retrieved or confirmed


Histologies for all polyps/lesions should be reviewed and a final diagnosis recorded in Item 9.2.


Right justify

Range check.


Leave blank if 7.0 = 0


Do not update/change this variable if polyp with high grade dysplasia is determined to be cancer during a subsequent surgery.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

7.13.1

Location of 13th polyp/lesion


Complete only if more than twelve polyps/lesions were removed.


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps.


2

395

396

1 = Rectum

2 = Rectosigmoid junction

3 = Sigmoid

4 = Descending

5 = Splenic flexure

6 = Transverse

7 = Hepatic flexure

8 = Ascending

9 = Cecum

10 = Appendix

11 = Overlapping lesions

99 = Unknown


Location will generally be found on the endoscopy report.


Right justify

Range check.

Leave blank if 7.0 = 0

7.13.2

Size of 13th polyp/lesion


This is the diameter of the polyp/lesion in millimeters (mm) or the longest dimension of the polyp/lesion if asymmetric.


NOTE: This should be the size of the actual polyp and not the size of the biopsy specimen submitted for pathology.

2

397

398

0 = < 1 mm

1 – 97 = Size of polyp/lesion in mm

98 = ≥ 98 mm

99 = Unknown


Right justify


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps. Size may be found on both the endoscopy and pathology reports, but size from the endoscopy report is preferred. If the specimen is not intact when sent to the pathology lab do NOT report specimen size from the pathology report.

Range check.


Leave blank if 7.0 = 0

7.13.3.1

Procedure for removal of 13th polyp/lesion (1)


This is the first procedure performed during removal/biopsy of the polyp/lesion.

1

399

399

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.13.3.2

Procedure for removal of 13th polyp/lesion (2)


This is the second procedure performed during removal/biopsy of the polyp/lesion.



1

400

400

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than one procedure was performed during the polyp/lesion removal.

7.13.3.3

Procedure for removal of 13th polyp/lesion (3)


This is the third procedure performed during removal/biopsy of the polyp/lesion.


1

401

401

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than two procedures were performed during the polyp/lesion removal.

7.13.4

Was 13th polyp/lesion completely removed?

1

402

402

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.13.5

Histology of 13th polyp/lesion


This is the histology of the polyp/lesion. If polyp was submitted to pathology as piecemeal fragments and more than one histological diagnosis was reported, report the worst (the response options are listed in general order of severity).


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy and pathology reports in order to “match up” the correct lesions.

2

403

404

1 = Normal or other non-polyp histology

2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)

3 = Hyperplastic polyp

4 = Adenoma, NOS (no high grade dysplasia noted)

5 = Adenoma, tubular (no high grade dysplasia noted)

6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)

7 = Adenoma, villous (no high grade dysplasia noted)

8 = Adenoma, serrated (no high grade dysplasia noted)

9 = Adenoma with high grade dysplasia (includes in situ carcinoma)

10 = Adenocarcinoma, invasive

11 = Carcinoma, other

99 = Unknown/other lesions ablated, not retrieved or confirmed


Histologies for all polyps/lesions should be reviewed and a final diagnosis recorded in Item 9.2.


Right justify

Range check.


Leave blank if 7.0 = 0


Do not update/change this variable if polyp with high grade dysplasia is determined to be cancer during a subsequent surgery.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

7.14.1

Location of 14th polyp/lesion


Complete only if more than thirteen polyps/lesions were removed.


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps.


2

405

406

1 = Rectum

2 = Rectosigmoid junction

3 = Sigmoid

4 = Descending

5 = Splenic flexure

6 = Transverse

7 = Hepatic flexure

8 = Ascending

9 = Cecum

10 = Appendix

11 = Overlapping lesions

99 = Unknown


Location will generally be found on the endoscopy report.


Right justify

Range check.

Leave blank if 7.0 = 0

7.14.2

Size of 14th polyp/lesion


This is the diameter of the polyp/lesion in millimeters (mm) or the longest dimension of the polyp/lesion if asymmetric.


NOTE: This should be the size of the actual polyp and not the size of the biopsy specimen submitted for pathology.

2

407

408

0 = < 1 mm

1 – 97 = Size of polyp/lesion in mm

98 = ≥ 98 mm

99 = Unknown


Right justify


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps. Size may be found on both the endoscopy and pathology reports, but size from the endoscopy report is preferred. If the specimen is not intact when sent to the pathology lab do NOT report specimen size from the pathology report.

Range check.


Leave blank if 7.0 = 0

7.14.3.1

Procedure for removal of 14th polyp/lesion (1)


This is the first procedure performed during removal/biopsy of the polyp/lesion.

1

409

409

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.14.3.2

Procedure for removal of 14th polyp/lesion (2)


This is the second procedure performed during removal/biopsy of the polyp/lesion.



1

410

410

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than one procedure was performed during the polyp/lesion removal.

7.14.3.3

Procedure for removal of 14th polyp/lesion (3)


This is the third procedure performed during removal/biopsy of the polyp/lesion.

1

411

411

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than two procedures were performed during the polyp/lesion removal.

7.14.4

Was 14th polyp/lesion completely removed?

1

412

412

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.14.5

Histology of 14th polyp/lesion


This is the histology of the polyp/lesion. If polyp was submitted to pathology as piecemeal fragments and more than one histological diagnosis was reported, report the worst (the response options are listed in general order of severity).


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy and pathology reports in order to “match up” the correct lesions.

2

413

414

1 = Normal or other non-polyp histology

2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)

3 = Hyperplastic polyp

4 = Adenoma, NOS (no high grade dysplasia noted)

5 = Adenoma, tubular (no high grade dysplasia noted)

6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)

7 = Adenoma, villous (no high grade dysplasia noted)

8 = Adenoma, serrated (no high grade dysplasia noted)

9 = Adenoma with high grade dysplasia (includes in situ carcinoma)

10 = Adenocarcinoma, invasive

11 = Carcinoma, other

99 = Unknown/other lesions ablated, not retrieved or confirmed


Histologies for all polyps/lesions should be reviewed and a final diagnosis recorded in Item 9.2.


Right justify

Range check.


Leave blank if 7.0 = 0


Do not update/change this variable if polyp with high grade dysplasia is determined to be cancer during a subsequent surgery.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

7.15.1

Location of 15th polyp/lesion


Complete only if more than fourteen polyps/lesions were removed.


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps.


2

415

416

1 = Rectum

2 = Rectosigmoid junction

3 = Sigmoid

4 = Descending

5 = Splenic flexure

6 = Transverse

7 = Hepatic flexure

8 = Ascending

9 = Cecum

10 = Appendix

11 = Overlapping lesions

99 = Unknown


Location will generally be found on the endoscopy report.


Right justify

Range check.

Leave blank if 7.0 = 0

7.15.2

Size of 15th polyp/lesion


This is the diameter of the polyp/lesion in millimeters (mm) or the longest dimension of the polyp/lesion if asymmetric.


NOTE: This should be the size of the actual polyp and not the size of the biopsy specimen submitted for pathology.

2

417

418

0 = < 1 mm

1 – 97 = Size of polyp/lesion in mm

98 = ≥ 98 mm

99 = Unknown


Right justify


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy report and pathology report in order to “match up” the correct polyps. Size may be found on both the endoscopy and pathology reports, but size from the endoscopy report is preferred. If the specimen is not intact when sent to the pathology lab do NOT report specimen size from the pathology report.

Range check.


Leave blank if 7.0 = 0

7.15.3.1

Procedure for removal of 15th polyp/lesion (1)


This is the first procedure performed during removal/biopsy of the polyp/lesion.

1

419

419

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.15.3.2

Procedure for removal of 15th polyp/lesion (2)


This is the second procedure performed during removal/biopsy of the polyp/lesion.



1

420

420

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than one procedure was performed during the polyp/lesion removal.

7.15.3.3

Procedure for removal of 15th polyp/lesion (3)


This is the third procedure performed during removal/biopsy of the polyp/lesion.


1

421

421

1 = Snare polypectomy

2 = Hot biopsy forceps or cautery

3 = Cold biopsy

4 = Ablation

5 = Submucosal injection

6 = Control of bleeding

7 = Not biopsied or removed

9 = Unknown

Range check.


Leave blank if 7.0 = 0


NOTE: This field should only be completed if more than two procedures were performed during the polyp/lesion removal.

7.15.4

Was 15th polyp/lesion completely removed?

1

422

422

1 = Yes

2 = No

9 = Unknown

Range check.


Leave blank if 7.0 = 0

7.15.5

Histology of 15th polyp/lesion


This is the histology of the polyp/lesion. If polyp was submitted to pathology as piecemeal fragments and more than one histological diagnosis was reported, report the worst (the response options are listed in general order of severity).


NOTE: The individual translating clinical data into the CCDEs will need to carefully compare the endoscopy and pathology reports in order to “match up” the correct lesions.

2

423

424

1 = Normal or other non-polyp histology

2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)

3 = Hyperplastic polyp

4 = Adenoma, NOS (no high grade dysplasia noted)

5 = Adenoma, tubular (no high grade dysplasia noted)

6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)

7 = Adenoma, villous (no high grade dysplasia noted)

8 = Adenoma, serrated (no high grade dysplasia noted)

9 = Adenoma with high grade dysplasia (includes in situ carcinoma)

10 = Adenocarcinoma, invasive

11 = Carcinoma, other

99 = Unknown/other lesions ablated, not retrieved or confirmed


Histologies for all polyps/lesions should be reviewed and a final diagnosis recorded in Item 9.2.


Right justify

Range check.


Leave blank if 7.0 = 0


Do not update/change this variable if polyp with high grade dysplasia is determined to be cancer during a subsequent surgery.


Reserved for future use

30

425

454


Leave blank.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

8. Diagnosis Information for Surgeries Performed to Complete Diagnosis

8.1

Histology from surgical resection


This is the worst histopathological diagnosis made from surgical resection (the response options are listed in general order of severity).

2

455

456

0 = Surgery recommended but not performed

1 = Normal or other non-polyp histology

2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)

3 = Hyperplastic polyp

4 = Adenoma, NOS (no high grade dysplasia noted)

5 = Adenoma, tubular (no high grade dysplasia noted)

6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)

7 = Adenoma, villous (no high grade dysplasia noted)

8 = Adenoma, serrated (no high grade dysplasia noted)

9 = Adenoma with high grade dysplasia (includes in situ carcinoma)

10 = Adenocarcinoma, invasive

11 = Carcinoma, other

99 = Unknown/other lesions ablated, not retrieved or confirmed


Use histology from surgical resection in conjunction with all of the polyp/lesion histologies in the Diagnosis Information for All Polyps/Lesions section, to report the “Final diagnosis” (9.2).


Right justify


Range check.


If surgery was recommended in 6.1.13, 6.2.13, 6.3.13 or 6.4.13 but was not completed, code 0 (Surgery recommended but not performed).


If no surgery was recommended in 6.1.13, 6.2.13, 6.3.13 or 6.4.13, leave blank.

8.2

Date surgery performed

The date of the surgical procedure used to complete diagnosis (recommended in 6.1.13, 6.2.13, 6.3.13 or 6.4.13).

8

457

464

MMDDYYYY


If just the year is known, blank fill the month and day. If just the year and month are known, blank fill the day (e.g. 04 2006).

MMDDYYYY”, “MM YYYY”, or “YYYY”.


If 6.1.13, 6.2.13, 6.3.13 or 6.4.13 = 4 (Surgery to complete diagnosis), then date must be completed.


If no surgery was recommended in 6.1.13, 6.2.13, 6.3.13 or 6.4.13, then leave blank.


If 8.1 = 0, then leave blank.


Reserved for future use

10

465

474


Leave blank.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

9. Final Diagnosis – Completed for all CCDE records

9.1

Status of diagnosis


After all screening and diagnostic tests were performed /offered to the client, what is the status of the client’s care?


1

475

475

1 = Complete (final diagnosis made)

2 = Pending final diagnosis

3 = Verbal/written refusal for any test needed to obtain a final diagnosis*

4 = Client moved before final diagnosis was made

5 = Client died before final diagnosis was made

6 = Lost to follow-up*

9 = Unknown


*Programs must have a policy in place to define how much time can elapse before the client is deemed refused or lost to follow-up.




Range check.


If a client receives a single screening test which is normal/negative, then complete this field as 1 (Complete).

9.2

Final diagnosis


This is the final diagnosis after all procedures have been completed (including surgery, if done) that will determine the re-screening or surveillance test recommendation.

1

476

476

1 = Normal/negative

2 = Polyp, no high grade dysplasia2

3 = Polyp with high grade dysplasia1,2

4 = Cancer1,2


1Diagnosis Information for Cancer/High Grade Dysplasia section must be completed if 9.2 “Final diagnosis” = 3, 4.


2Treatment section must be completed if 9.2 “Final diagnosis” = 2, 3, 4.


Range check.


If the only test performed in cycle was FOBT or FIT, then complete this field as 1 (Normal/negative).



9.3

Date of diagnosis


This can be the date of the final pathology report, the date of the ‘normal’ screening test, or when the client refused or was determined to be lost to follow-up.

8

477

484

MMDDYYYY


If just the year is known, blank fill the month and day. If just the year and month are known, blank fill the day (e.g. 04 2006).

If 9.1 = 1, 3-6, then “MMDDYYYY”, “MM YYYY” or “YYYY”.



If 9.1 = 3-6, then an administrative close-out date will be necessary.


Leave blank if 9.1 = 2, 9

9.4

Recommended screening or surveillance test for next cycle


The next screening or surveillance test recommended to the client at the end of the cycle. This can be a surveillance colonoscopy following a previous abnormal colonoscopy and/or surgery, or the next screening test recommended to the client following a normal/negative test.

1

485

485

1 = Take-home FOBT

2 = Take-home FIT

3 = Sigmoidoscopy

4 = Colonoscopy

5 = DCBE

6 = None

9 = Unknown

Range check.


If client is terminally ill or for other reasons no further tests are recommended, then code this as 6 (None).


Leave blank if 9.1 ≠ 1

9.5

Indication for screening or surveillance test for next cycle


The indication for the next screening or surveillance test recommended to the client.

1

486

486

1 = Screening

2 = Surveillance after a positive colonoscopy and/or surgery


Range check.


Leave blank if 9.4 = 6, 9

9.6

Number of months before screening or surveillance test for next cycle


The number of months recommended between Date of diagnosis (9.3) and next recommended screening or surveillance test.

3

487

489

12 – 180 = Actual number of months

999 = Unknown




Right Justify

Range check.


Leave blank if 9.4 = 6, 9




Reserved for future use

10

490

499


Leave blank.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

10. Diagnosis Information for Cancer/High Grade Dysplasia – Complete this section when Final Diagnosis (9.2) = 3 or 4

10.1

Stage at diagnosis/treatment


AJCC cancer stage used as a basis for clinical decisions. This can be based on clinical and/or pathological information.

1

500

500

0 = Stage 0 (high grade dysplasia, severe dysplasia, or in situ)

1 = Stage I

2 = Stage II

3 = Stage III

4 = Stage IV

9 = Unknown/unstaged

Range check.


If “Final diagnosis” (9.2) = 3 (High grade dysplasia) or 4 (Cancer), then 10.1 must be completed.

10.2

Recurrent cancers


Is this cancer a new primary or a recurrent cancer?

1

501

501

1 = New CRC primary

2 = Recurrent CRC

3 = Non-CRC primary (metastasis from another organ)

9 = Unknown

Range check.



10.3

Registry linkage status


Has this record been linked to the state cancer registry?

1

502

502

1 = Pending linkage

2 = Linked, matched

3 = Linked, not matched

Range check.

10.4

Registry primary site


Primary site [NAACCR data item #400] obtained from the central cancer registry.


See SEER Program Coding and Staging Manual (pg 73):

http://seer.cancer.gov/manuals/SPM2004.pdf

4

503

506

C000-C999



NOTE: The ‘C’ must be included as part of the variable response in the CCDE file. For example Cecum = C180. A complete list of valid values/labels will be provided for reference in the CCDE User’s Manual.




Alphanumeric, left justify

Range check.


Leave blank if 10.3 = 1, 3


10.5

Registry CS-derived SS2000


Collaborative stage (CS)-derived summary stage 2001 [NAACCR data item #3020] obtained from the central cancer registry database.


See CS Staging Manual (pg 67) & SEER Summary Staging Manual:

http://www.cancerstaging.org/cstage/csmanualpart1.pdf

http://seer.cancer.gov/tools/ssm/

1

507

507

0 = In situ

1 = Localized

2 = Regional, direct extension only

3 = Regional, regional lymph nodes only

4 = Regional, extension and nodes

5 = Regional, NOS

7 = Distant

8 = Not applicable

9 = Unknown/unstaged

Range check.


Leave blank if 10.3 = 1, 3


10.6

Registry CS-derived AJCC stage group


Collaborative stage (CS)-derived AJCC stage [NAACCR date Item #3000] obtained from the central cancer registry database WHEN AVAILABLE.


See CS Staging Manual (pg 65):

http://www.cancerstaging.org/cstage/csmanualpart1.pdf

2

508

509

Range: 00-99



Valid values for CS-derived AJCC stage include: 00-02, 10-24, 30-43, 50-63, 70-74, 88, 90, 99.


A complete list of valid values/labels will be provided for reference in the CCDE User’s Manual.

Range check.


Leave blank if 10.3 = 1, 3


10.7

Registry CS extension


Collaborative stage (CS) extension [NAACCR data item #2810] obtained from the central cancer registry database.


See CS Staging Manual (pg 272): http://www.cancerstaging.org/cstage/csmanualpart2.pdf

2

510

511

Range: 00-99



Valid values for CS extension include: 00, 05, 10-16, 20, 30, 40, 42, 45, 46, 50, 55, 57, 60, 65, 66, 70, 75, 80, 95, 99.


A complete list of valid values/labels will be provided for reference in the CCDE User’s Manual.

Range check.


Leave blank if 10.3 = 1, 3


10.8

Registry CS lymph nodes


Collaborative stage (CS) lymph nodes [NAACCR data item #2830] obtained from the central cancer registry database.


See CS Staging Manual (pg 274):

http://www.cancerstaging.org/cstage/csmanualpart2.pdf

2

512

513

Range: 00-99



Valid values for CS lymph nodes include: 00, 10, 20, 30, 80, 99.


A complete list of valid values/labels will be provided for reference in the CCDE User’s Manual.

Range check.


Leave blank if 10.3 = 1, 3


10.9

Registry CS mets at diagnosis


Collaborative stage (CS) mets at diagnosis [NAACCR data item #2850] obtained from the central cancer registry database.


See CS Staging Manual (pg 275):

http://www.cancerstaging.org/cstage/csmanualpart2.pdf

2

514

515

Range: 00-99



Valid values for CS mets at diagnosis include: 00, 08, 10, 40, 50, 99.


A complete list of valid values/labels will be provided for reference in the CCDE User’s Manual.

Range check.


Leave blank if 10.3 = 1, 3



Reserved for future use

10

516

525


Leave blank.

Item

Variable Name

Column
Length Begin End

Codes / Format / Comments

Edit Checks / Skip Patterns

11. Treatment Information - Complete this section when Final Diagnosis (9.2) = 2, 3 or 4

11.1

Status of treatment


In some cases, a polypectomy may be considered both diagnostic and treatment. In other cases surgery may be considered both diagnostic and start of treatment.


1

526

526

1 = Treatment started and/or completed

2 = Treatment pending

3 = Treatment not indicated

4 = Verbal/written refusal of treatment*

5 = Client moved

6 = Deceased

7 = Lost to follow-up*

9 = Unknown


*Programs must have a policy in place to define how much time can elapse before the client is deemed refused or lost to follow-up.

Range check.


If “Final diagnosis” (9.2) = 2, 3, 4, then 11.1 must be completed.

11.2

Date of treatment


Can be the date treatment began, when the client refused, or was determined to be lost to follow-up. Date that treatment began may be the date of one of the tests. For instance, if a polypectomy was done and cancer was found and removed, the date that the polyp(s) was removed would also be the date that treatment began.


8

527

534

MMDDYYYY


If just the year is known, blank fill the month and day. If just the year and month are known, blank fill the day (e.g. 04 2006).

If 11.1 = 1, 3-7, then “MMDDYYYY”, “MM YYYY” or “YYYY”.


If 11.1 = 3-7, then an administrative close-out date will be necessary.


Leave blank if 11.1 = 2, 9

11.3

Who paid for treatment?


This is the primary source of payment for treatment.

1

535

535

1 = Medicaid

2 = Other, State

3 = Medicare

4 = Self-Pay (by client)

5 = Charity care/uncompensated

6 = Other

9 = Unknown

Range check.


Leave blank if 11.1 ≠ 1 (Treatment started).


Reserved for future use

10

536

545

Leave blank.

12. Record Information – Completed for each CCDE record

12.1

CCDE version

3

546

548

100 = For all data currently collected/reported

Range check.

12.2

End of record mark

2

549

550

The record ends with a carriage return-line feed (CR-LF).




4

CCDE Version 1.00 February 6, 2006

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File TitleTable of Contents:
Authorlvs3
Last Modified Byarp5
File Modified2007-02-05
File Created2007-02-05

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