Medical Record Abstraction

Case Investigation of Cervical Cancer (CICC) Study

Attachment 9. Chart Abstraction Form

Support for Medical Record Abstraction

OMB: 0920-1162

Document [docx]
Download: docx | pdf



Attachment 9


Chart Abstraction Form


i. Chart Abstraction Information

i.1 This chart abstraction form is (check one):

a. a consolidated form

(i.e., combined records from all sources)

b. a facility-specific form

(i.e., record from one provider/facility only)

i.2 If i.1 = b, enter Provider Study ID:

If i.1 = a, enter Provider Study ID as indicated below in Tables I, II, and III


  1. Patient Demographics

A.1 Study ID Number:

A.2 Month and Year of Birth: ____ /____

A.3 Hispanic or Latino origin:

Yes

No

Unknown

A.4 Race (check all that apply):

White/Caucasian

Asian

Native Hawaiian/Pacific Islander

African American

American Indian/Alaskan Native

Other

Unknown

  1. Cervical Cancer Diagnosis

5-year Review Period



(registry to provide these dates)

B.1 Date 5 years prior to diagnosis (start of 5-year review period):

____ /____ /____

MM/DD/YY

B.2 Date of diagnosis (end of 5-year review period):

____ /____ /____

MM/DD/YY

B.3 Patient had tubal ligation prior to diagnosis (B.2)? Yes No

B.4 Did patient undergo a cervical procedure (e.g., LEEP or cold knife cone biopsy) prior to review period (B.1)? Yes No

B.5 Has the patient had a hysterectomy? Yes No (If B.5 = YES, complete B.6 and B.7)

B.6 Date of hysterectomy: ____ /____ /____

MM/DD/YY

B.7 Was cervical cancer found as a result of the hysterectomy? Yes No


  1. Cervical Cancer Screening

C.1 Has patient had a PAP or HPV test during the 5-year review period?

Yes No

(If YES, please complete TABLE I for all Pap and HPV results during the review period)



Table I. Pap and HPV Testing, review period only


C.2

C.3

C.4

C.5

C.6

C.7

C.8

C.9

C.10

C.11

C.12

C.13

C.14

C.15

C.16

C.17






Pap Testing (if C.3 = Pap or Both)

HPV Testing (if C.3 = HPV or Both)



PAP, HPV

Date of Test(s)

Test(s) Performed

Test(s) Performed by

Provider Study ID

(If i.1 = a)

Type of Pap

Lab where run? (Name)

Image-based evaluation?

Satisfactory test result?

Endocervical/

TZ component present?

Pap result

(check all that apply)

Type of HPV

HPV result

HPV

genotyping performed?

(check all that apply)

Results of genotyping? (record result for each test in C.14)

Was patient referred to colposcopy/ treatment?

Did patient return for colposcopy/ treatment?

1

____ /____ /____

MM/DD/YY



Pap

HPV

Both

Family practice

Primary care physician

Gynecologist

Gyn/onc

Advanced Practice Clinician (APN, PA, NP)

Other (specify)

____________________






STM/ Glass slide

ThinPrep

SurePath

Not reported




Yes

No

Not reported or Not available



Yes

No

Not reported



Yes

No

Not reported

Normal

ASC-US

ASC-H

LSIL

HSIL

AGC

Squamous CA

Other (specify)

_______________

Qiagen

Cervista

Roche Cobas

Aptima

Laboratory Developed Test (LDT)

Not Specific



Positive HR

Negative HR

Indeterminate

Not reported

HPV 16


Pos. Neg.

Not Rep. N/A



Yes

No

Not reported



Yes

No

Not reported

HPV 18


Pos. Neg.

Not Rep. N/A

HPV 45


Pos. Neg.

Not Rep. N/A

HPV 18/ 45

Pos. Neg.

Not Rep. N/A

Other:

__________

Pos. Neg.

Not Rep. N/A

2

____ /____ /____

MM/DD/YY



Pap

HPV

Both

Family practice

Primary care physician

Gynecologist

Gyn/onc

Advanced Practice Clinician (APN, PA, NP)

Other (specify)

____________________






STM/ Glass slide

ThinPrep

SurePath

Not reported




Yes

No

Not reported or Not available



Yes

No

Not reported



Yes

No

Not reported

Normal

ASC-US

ASC-H

LSIL

HSIL

AGC

Squamous CA

Other (specify)

_______________

Qiagen

Cervista

Roche Cobas

Aptima

Laboratory Developed Test (LDT)

Not Specific



Positive HR

Negative HR

Indeterminate

Not reported

HPV 16


Pos. Neg.

Not Rep. N/A



Yes

No

Not reported



Yes

No

Not reported

HPV 18


Pos. Neg.

Not Rep. N/A

HPV 45


Pos. Neg.

Not Rep. N/A

HPV 18/ 45

Pos. Neg.

Not Rep. N/A

Other:

__________

Pos. Neg.

Not Rep. N/A

3

____ /____ /____

MM/DD/YY



Pap

HPV

Both

Family practice

Primary care physician

Gynecologist

Gyn/onc

Advanced Practice Clinician (APN, PA, NP)

Other (specify)

____________________






STM/ Glass slide

ThinPrep

SurePath

Not reported




Yes

No

Not reported or Not available



Yes

No

Not reported



Yes

No

Not reported

Normal

ASC-US

ASC-H

LSIL

HSIL

AGC

Squamous CA

Other (specify)

_______________

Qiagen

Cervista

Roche Cobas

Aptima

Laboratory Developed Test (LDT)

Not Specific



Positive HR

Negative HR

Indeterminate

Not reported

HPV 16


Pos. Neg.

Not Rep. N/A



Yes

No

Not reported



Yes

No

Not reported

HPV 18


Pos. Neg.

Not Rep. N/A

HPV 45


Pos. Neg.

Not Rep. N/A

HPV 18/ 45

Pos. Neg.

Not Rep. N/A

Other:

__________

Pos. Neg.

Not Rep. N/A

4

____ /____ /____

MM/DD/YY



Pap

HPV

Both

Family practice

Primary care physician

Gynecologist

Gyn/onc

Advanced Practice Clinician (APN, PA, NP)

Other (specify)

____________________






STM/ Glass slide

ThinPrep

SurePath

Not reported




Yes

No

Not reported or Not available



Yes

No

Not reported



Yes

No

Not reported

Normal

ASC-US

ASC-H

LSIL

HSIL

AGC

Squamous CA

Other (specify)

_______________

Qiagen

Cervista

Roche Cobas

Aptima

Laboratory Developed Test (LDT)

Not Specific



Positive HR

Negative HR

Indeterminate

Not reported

HPV 16


Pos. Neg.

Not Rep. N/A



Yes

No

Not reported



Yes

No

Not reported

HPV 18


Pos. Neg.

Not Rep. N/A

HPV 45


Pos. Neg.

Not Rep. N/A

HPV 18/ 45

Pos. Neg.

Not Rep. N/A

Other:

__________

Pos. Neg.

Not Rep. N/A

5

____ /____ /____

MM/DD/YY



Pap

HPV

Both

Family practice

Primary care physician

Gynecologist

Gyn/onc

Advanced Practice Clinician (APN, PA, NP)

Other (specify)

____________________






STM/ Glass slide

ThinPrep

SurePath

Not reported




Yes

No

Not reported or Not available



Yes

No

Not reported



Yes

No

Not reported

Normal

ASC-US

ASC-H

LSIL

HSIL

AGC

Squamous CA

Other (specify)

_______________

Qiagen

Cervista

Roche Cobas

Aptima

Laboratory Developed Test (LDT)

Not Specific



Positive HR

Negative HR

Indeterminate

Not reported

HPV 16


Pos. Neg.

Not Rep. N/A



Yes

No

Not reported



Yes

No

Not reported

HPV 18


Pos. Neg.

Not Rep. N/A

HPV 45


Pos. Neg.

Not Rep. N/A

HPV 18/ 45

Pos. Neg.

Not Rep. N/A

Other:

__________

Pos. Neg.

Not Rep. N/A

6

____ /____ /____

MM/DD/YY



Pap

HPV

Both

Family practice

Primary care physician

Gynecologist

Gyn/onc

Advanced Practice Clinician (APN, PA, NP)

Other (specify)

____________________






STM/ Glass slide

ThinPrep

SurePath

Not reported




Yes

No

Not reported or Not available



Yes

No

Not reported



Yes

No

Not reported

Normal

ASC-US

ASC-H

LSIL

HSIL

AGC

Squamous CA

Other (specify)

_______________

Qiagen

Cervista

Roche Cobas

Aptima

Laboratory Developed Test (LDT)

Not Specific



Positive HR

Negative HR

Indeterminate

Not reported

HPV 16


Pos. Neg.

Not Rep. N/A



Yes

No

Not reported



Yes

No

Not reported

HPV 18


Pos. Neg.

Not Rep. N/A

HPV 45


Pos. Neg.

Not Rep. N/A

HPV 18/ 45

Pos. Neg.

Not Rep. N/A

Other:

__________

Pos. Neg.

Not Rep. N/A

7

____ /____ /____

MM/DD/YY



Pap

HPV

Both

Family practice

Primary care physician

Gynecologist

Gyn/onc

Advanced Practice Clinician (APN, PA, NP)

Other (specify)

____________________






STM/ Glass slide

ThinPrep

SurePath

Not reported




Yes

No

Not reported or Not available



Yes

No

Not reported



Yes

No

Not reported

Normal

ASC-US

ASC-H

LSIL

HSIL

AGC

Squamous CA

Other (specify)

_______________

Qiagen

Cervista

Roche Cobas

Aptima

Laboratory Developed Test (LDT)

Not Specific



Positive HR

Negative HR

Indeterminate

Not reported

HPV 16


Pos. Neg.

Not Rep. N/A



Yes

No

Not reported



Yes

No

Not reported

HPV 18


Pos. Neg.

Not Rep. N/A

HPV 45


Pos. Neg.

Not Rep. N/A

HPV 18/ 45

Pos. Neg.

Not Rep. N/A

Other:

__________

Pos. Neg.

Not Rep. N/A

8

____ /____ /____

MM/DD/YY



Pap

HPV

Both

Family practice

Primary care physician

Gynecologist

Gyn/onc

Advanced Practice Clinician (APN, PA, NP)

Other (specify)

____________________






STM/ Glass slide

ThinPrep

SurePath

Not reported




Yes

No

Not reported or Not available



Yes

No

Not reported



Yes

No

Not reported

Normal

ASC-US

ASC-H

LSIL

HSIL

AGC

Squamous CA

Other (specify)

_______________

Qiagen

Cervista

Roche Cobas

Aptima

Laboratory Developed Test (LDT)

Not Specific



Positive HR

Negative HR

Indeterminate

Not reported

HPV 16


Pos. Neg.

Not Rep. N/A



Yes

No

Not reported



Yes

No

Not reported

HPV 18


Pos. Neg.

Not Rep. N/A

HPV 45


Pos. Neg.

Not Rep. N/A

HPV 18/ 45

Pos. Neg.

Not Rep. N/A

Other:

__________

Pos. Neg.

Not Rep. N/A

9

____ /____ /____

MM/DD/YY



Pap

HPV

Both

Family practice

Primary care physician

Gynecologist

Gyn/onc

Advanced Practice Clinician (APN, PA, NP)

Other (specify)

____________________






STM/ Glass slide

ThinPrep

SurePath

Not reported




Yes

No

Not reported or Not available



Yes

No

Not reported



Yes

No

Not reported

Normal

ASC-US

ASC-H

LSIL

HSIL

AGC

Squamous CA

Other (specify)

_______________

Qiagen

Cervista

Roche Cobas

Aptima

Laboratory Developed Test (LDT)

Not Specific



Positive HR

Negative HR

Indeterminate

Not reported

HPV 16


Pos. Neg.

Not Rep. N/A



Yes

No

Not reported



Yes

No

Not reported

HPV 18


Pos. Neg.

Not Rep. N/A

HPV 45


Pos. Neg.

Not Rep. N/A

HPV 18/ 45

Pos. Neg.

Not Rep. N/A

Other:

__________

Pos. Neg.

Not Rep. N/A

10

____ /____ /____

MM/DD/YY



Pap

HPV

Both

Family practice

Primary care physician

Gynecologist

Gyn/onc

Advanced Practice Clinician (APN, PA, NP)

Other (specify)

____________________






STM/ Glass slide

ThinPrep

SurePath

Not reported




Yes

No

Not reported or Not available



Yes

No

Not reported



Yes

No

Not reported

Normal

ASC-US

ASC-H

LSIL

HSIL

AGC

Squamous CA

Other (specify)

_______________

Qiagen

Cervista

Roche Cobas

Aptima

Laboratory Developed Test (LDT)

Not Specific



Positive HR

Negative HR

Indeterminate

Not reported

HPV 16


Pos. Neg.

Not Rep. N/A



Yes

No

Not reported



Yes

No

Not reported

HPV 18


Pos. Neg.

Not Rep. N/A

HPV 45


Pos. Neg.

Not Rep. N/A

HPV 18/ 45

Pos. Neg.

Not Rep. N/A

Other:

__________

Pos. Neg.

Not Rep. N/A



  1. Cervical Cancer Diagnostic Testing

D.1 Has patient had a COLPOSCOPY (with or without CERVICAL or ENDOCERVICAL BIOPSIES) during the 5-year review period?

Yes No

(If YES, please complete TABLE II for all COLPOSCOPY and BIOPSY results during the review period)


Table II. Colposcopies and Biopsies, review period only


D.2

D.3

D.4

D.5

D.6

D.7

D.8

D.9.a

D.9.b

D.9.c

D.9.d

D.10

D.11

D.12

D.13







Cervical Biopsies (if D.6 = Cervical or Both)

ECC (if D.6 = ECC or Both)




COLPOSOPY

Date of colpo-scopy

Colposcopy performed by

Provider Study ID

(If i.1 = a)

Were cervical biopsies or Endocervical Curettage (ECC) performed?

Type of Biospy/ Biopsies

(choose one)

Number of cervical biopsy specimens

Number of cervical biopsy test results returned

Cervical biopsy test results: specimen 1, or all specimens if combined

(check all that apply)

Cervical biopsy test results: specimen 2

(check all that apply)

Cervical biopsy test results: specimen 3

(check all that apply)

Cervical biopsy test results: specimen 4

(check all that apply)

Endocervical Curettage (ECC) test results

(check all that apply)

Was patient referred to treatment/ diagnosis?

Did patient return for treatment/ diagnosis?

Comments (e.g., biopsy results for more than 4 specimens)

1

____ /____ /____

MM/DD/YY



Family practice

Primary care physician

Gynecologist

Gyn/onc

Advanced Practice Clinician (APN, PA, NP)

Other (specify) ____________________






Yes

No

(if no, skip to next colposcopy)



Cervical

Endocervical Curettage (ECC)

Both



1

2

3

4

> 4



1

2

3

4

> 4

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________



Yes

No

Not reported



Yes

No

Not reported


2

____ /____ /____

MM/DD/YY



Family practice

Primary care physician

Gynecologist

Gyn/onc

Advanced Practice Clinician (APN, PA, NP)

Other (specify) ____________________






Yes

No

(if no, skip to next colposcopy)



Cervical

Endocervical Curettage (ECC)

Both



1

2

3

4

> 4



1

2

3

4

> 4

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________



Yes

No

Not reported



Yes

No

Not reported


3

____ /____ /____

MM/DD/YY



Family practice

Primary care physician

Gynecologist

Gyn/onc

Advanced Practice Clinician (APN, PA, NP)

Other (specify) ____________________






Yes

No

(if no, skip to next colposcopy)



Cervical

Endocervical Curettage (ECC)

Both



1

2

3

4

> 4



1

2

3

4

> 4

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________



Yes

No

Not reported



Yes

No

Not reported


4

____ /____ /____

MM/DD/YY



Family practice

Primary care physician

Gynecologist

Gyn/onc

Advanced Practice Clinician (APN, PA, NP)

Other (specify) ____________________






Yes

No

(if no, skip to next colposcopy)



Cervical

Endocervical Curettage (ECC)

Both



1

2

3

4

> 4



1

2

3

4

> 4

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________

Normal

CIN1

CIN2

CIN3

CIN2/3

AIS

LSIL

HSIL

CA

Other (specify)

______________



Yes

No

Not reported



Yes

No

Not reported




  1. Diagnosis

E.1 Was DIAGNOSIS OR TREATMENT PROCEDURE REQUIRED as a result of pap or biopsy test results during the 5-year review period?

Yes No

(If YES, please complete TABLE III for all DIAGNOSTIC AND EXCISIONAL PROCEDURES RECEIVED during the review period.)


Table III. Diagnostic procedures received, review period only


E.1

E.2

E.3

E.4

PROCEDURE

Date of diagnostic procedure/treatment

Diagnostic procedure/treatment performed by

Provider Study ID

(If i.1 = a)

Type of diagnostic procedure/treatment

(check all that apply)

1



____ /____ /____

MM/DD/YY

Family practice

Primary care physician

Gynecologist

Gyn/onc

Advanced Practice Clinician (APN, PA, NP)

Other (specify) ______________________




LEEP

Cold knife cone

CO2 Laser therapy

Cryo

Other:

____________________

2



____ /____ /____

MM/DD/YY

Family practice

Primary care physician

Gynecologist

Gyn/onc

Advanced Practice Clinician (APN, PA, NP)

Other (specify) ______________________




LEEP

Cold knife cone

CO2 Laser therapy

Cryo

Other:

____________________

3



____ /____ /____

MM/DD/YY

Family practice

Primary care physician

Gynecologist

Gyn/onc

Advanced Practice Clinician (APN, PA, NP)

Other (specify) ______________________




LEEP

Cold knife cone

CO2 Laser therapy

Cryo

Other:

____________________

4



____ /____ /____

MM/DD/YY

Family practice

Primary care physician

Gynecologist

Gyn/onc

Advanced Practice Clinician (APN, PA, NP)

Other (specify) ______________________




LEEP

Cold knife cone

CO2 Laser therapy

Cryo

Other:

____________________


  1. Other Patient History

F.1 Has patient experienced symptoms of cervical disease during the 5-year review period?

Yes

No



(IF F.1 = YES, complete F.2)


F.2 Check all that apply.

Abnormal bleeding

Bleeding after intercourse

Discharge

Pain

Urinary symptoms

Other


1

File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorAmy Dancisak
File Modified0000-00-00
File Created2021-01-21

© 2024 OMB.report | Privacy Policy