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) |
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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 |
Patient Demographics
A.1 Study ID Number: |
A.2 Month and Year of Birth: ____ /____ |
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A.3 Hispanic or Latino origin: |
Yes |
No |
Unknown |
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A.4 Race (check all that apply): |
White/Caucasian |
Asian |
Native Hawaiian/Pacific Islander |
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African American |
American Indian/Alaskan Native |
Other |
Unknown |
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 |
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B.4 Did patient undergo a cervical procedure (e.g., LEEP or cold knife cone biopsy) prior to review period (B.1)? Yes No |
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B.5 Has the patient had a hysterectomy? Yes No (If B.5 = YES, complete B.6 and B.7) |
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B.6 Date of hysterectomy: ____ /____ /____ MM/DD/YY |
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B.7 Was cervical cancer found as a result of the hysterectomy? Yes No |
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
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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 |
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Pap Testing (if C.3 = Pap or Both) |
HPV Testing (if C.3 = HPV or Both) |
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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 |
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HPV 45
|
Pos. Neg. Not Rep. N/A |
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HPV 18/ 45 |
Pos. Neg. Not Rep. N/A |
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Other: __________ |
Pos. Neg. Not Rep. N/A |
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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 |
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HPV 45
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Pos. Neg. Not Rep. N/A |
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HPV 18/ 45 |
Pos. Neg. Not Rep. N/A |
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Other: __________ |
Pos. Neg. Not Rep. N/A |
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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 |
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HPV 45
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Pos. Neg. Not Rep. N/A |
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HPV 18/ 45 |
Pos. Neg. Not Rep. N/A |
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Other: __________ |
Pos. Neg. Not Rep. N/A |
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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
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Pos. Neg. Not Rep. N/A |
Yes No Not reported |
Yes No Not reported |
HPV 18
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Pos. Neg. Not Rep. N/A |
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HPV 45
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Pos. Neg. Not Rep. N/A |
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HPV 18/ 45 |
Pos. Neg. Not Rep. N/A |
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Other: __________ |
Pos. Neg. Not Rep. N/A |
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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
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Pos. Neg. Not Rep. N/A |
Yes No Not reported |
Yes No Not reported |
HPV 18
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Pos. Neg. Not Rep. N/A |
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HPV 45
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Pos. Neg. Not Rep. N/A |
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HPV 18/ 45 |
Pos. Neg. Not Rep. N/A |
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Other: __________ |
Pos. Neg. Not Rep. N/A |
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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
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Pos. Neg. Not Rep. N/A |
Yes No Not reported |
Yes No Not reported |
HPV 18
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Pos. Neg. Not Rep. N/A |
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HPV 45
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Pos. Neg. Not Rep. N/A |
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HPV 18/ 45 |
Pos. Neg. Not Rep. N/A |
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Other: __________ |
Pos. Neg. Not Rep. N/A |
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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
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Pos. Neg. Not Rep. N/A |
Yes No Not reported |
Yes No Not reported |
HPV 18
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Pos. Neg. Not Rep. N/A |
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HPV 45
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Pos. Neg. Not Rep. N/A |
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HPV 18/ 45 |
Pos. Neg. Not Rep. N/A |
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Other: __________ |
Pos. Neg. Not Rep. N/A |
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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 |
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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
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Pos. Neg. Not Rep. N/A |
Yes No Not reported |
Yes No Not reported |
HPV 18
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Pos. Neg. Not Rep. N/A |
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HPV 45
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Pos. Neg. Not Rep. N/A |
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HPV 18/ 45 |
Pos. Neg. Not Rep. N/A |
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Other: __________ |
Pos. Neg. Not Rep. N/A |
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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
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Pos. Neg. Not Rep. N/A |
Yes No Not reported |
Yes No Not reported |
HPV 18
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Pos. Neg. Not Rep. N/A |
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HPV 45
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Pos. Neg. Not Rep. N/A |
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HPV 18/ 45 |
Pos. Neg. Not Rep. N/A |
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Other: __________ |
Pos. Neg. Not Rep. N/A |
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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 |
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HPV 45
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Pos. Neg. Not Rep. N/A |
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HPV 18/ 45 |
Pos. Neg. Not Rep. N/A |
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Other: __________ |
Pos. Neg. Not Rep. N/A |
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
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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 |
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Cervical Biopsies (if D.6 = Cervical or Both) |
ECC (if D.6 = ECC or Both) |
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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 |
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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 |
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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 |
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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
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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: ____________________ |
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 |
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | Amy Dancisak |
File Modified | 0000-00-00 |
File Created | 2021-01-21 |