Att F_Chart Review Plan_0209

Att F_Chart Review Plan_0209.doc

CDC Cervical Cancer Study (CX3)

Att F_Chart Review Plan_0209

OMB: 0920-0814

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Chart Review Plan



The proposed study will be conducted over a 5-year period. In year 4, clinic coordinators will collect information about patient diagnoses and outcomes through medical chart reviews. The collection of this information is not requested during the initial three-year OMB clearance period. However, an overview of the information to be collected in year 4 is provided as context for the current OMB clearance request.


Information from medical records is required to examine the follow-up care provided to women with a positive HPV test result. At the time of study enrollment, patients are asked to give consent for study personnel to access their medical records. The records will only be examined for women with either an abnormal Pap test or a positive HPV test result (or both). The variables that will be obtained through this method are specified in the table below.



Description

Response options

For all patients that are HPV+ and/or Pap+

Type of follow-up test performed

  • Pap test

  • HPV DNA test (Hybrid Capture 2)

  • HPV DNA test (other brands)

  • HPV genotype test

  • Other HPV test

  • Colposcopy

  • Biopsy

  • Cone biopsy conization

  • Cryotherapy

  • Laser ablation

  • Cervical ultrasound

  • Cold knife cone

  • Excision of endocervical polyps

  • Cervicography

  • Endometrial sampling

  • Other

If Pap test performed

Date of Pap test

MM/DD/YYYY

If Pap test performed

Type of Pap test

  • Conventional

  • Liquid based

If Pap test performed

Result of Pap test

  • Negative/within normal limits (WNL)/Negative for intraepithelial lesion or malignancy

  • Infection/Inflammation/Reactive changes

  • Atypical squamous cells of undetermined significance (ASCUS or ASC-US)

  • Low grade SIL (including HPV changes)

  • Atypical squamous cells cannot exclude HSIL (ASC-H)

  • High grade SIL (HSIL)

  • Abnormal glandular cells (including AGUS, AGC, and adenocarcinoma)

  • Other

If HPV DNA test (Hybrid Capture 2) performed

Date of HPV DNA test (Hybrid Capture 2)

MM/DD/YYYY

If HPV DNA test (Hybrid Capture 2) performed

Result of HPV DNA test (Hybrid Capture 2)

  • Positive for high risk

  • Negative for high risk

If other HPV DNA test performed

Date of other HPV DNA test

MM/DD/YYYY

If other HPV DNA test performed

Results of other HPV DNA test

  • Positive for high risk

  • Negative for high risk

If HPV genotype test performed

Date of HPV genotype test


MM/DD/YYYY

If HPV genotype test performed

Test positive for type 16

  • Yes

  • No

If HPV genotype test performed

Test positive for type 18

  • Yes

  • No

If HPV genotype test performed

Test positive for other HPV types (besides 16 and 18)

  • Yes

  • No

If colposcopy performed

Date of colposcopy

MM/DD/YYYY

If colposcopy performed

Colposcopy results

  • Satisfactory

  • Unsatisfactory

If colposcopy performed

Impression (see doctor’s notes)

  • Normal or benign reaction or inflammation

  • Squamous metaplasia

  • HPV or condylomata or atypia

  • CIN I/mild dysplasia

  • CIN II/moderate dysplasia

  • CIN III/severe dysplasia

  • In situ cervical cancer

  • Adenocarcinoma in situ of cervix

  • Invasive cervical cancer

  • Other cancer

  • Adenocarcinoma of the cervix

  • Endometrial cancer

  • Vaginal cancer

  • Vulvar cancer

  • Ovarian cancer

  • Cervical polyps

  • Vaginal intraepithelial neoplasm (VAIN)-specify VAIN 1, 2, 3

  • Vulvar intraepithelial neoplasm (VIN)--specify VIN 1, 2, 3

If biopsy performed

Date of biopsy

MM/DD/YYYY

If biopsy performed

Type of biopsy

  • Ectocervical

  • Endocervical

  • Vaginal

  • Vulvar

If biopsy performed

Biopsy results

  • Normal or benign reaction or inflammation

  • Squamous metaplasia

  • HPV or condylomata or atypia

  • CIN I/mild dysplasia

  • CIN II/moderate dysplasia

  • CIN III/severe dysplasia

  • In situ cervical cancer

  • Adenocarcinoma in situ of cervix

  • Invasive cervical cancer

  • Other cancer

  • Adenocarcinoma of the cervix

  • Endometrial cancer

  • Vaginal cancer

  • Vulvar cancer

  • Ovarian cancer

  • Cervical polyps

  • Vaginal intraepithelial neoplasm (VAIN)-specify VAIN 1, 2, 3

  • Vulvar intraepithelial neoplasm (VIN)--specify VIN 1, 2, 3

If cone biopsy conization performed

Date of cone biopsy conization

MM/DD/YYYY

If cone biopsy conization performed

Results of cone biopsy conization

  • Margins positive

  • Margins negative

If cryotherapy performed


Date of cryotherapy


MM/DD/YYYY

If laser ablation

performed

Date of laser ablation

MM/DD/YYYY

If cervical ultrasound performed

Date of cervical ultrasound

MM/DD/YYYY

If cold knife cone performed

Date of cold knife cone

MM/DD/YYYY

If cold knife cone performed

Results of cold knife cone

  • Margins positive

  • Margins negative

If endocervical polyps were excised

Date endocervical polyps were excised

MM/DD/YYYY

If endocervical polyps were excised

Results of excision of endocervical polyps

  • Normal or benign reaction or inflammation

  • Squamous metaplasia

  • HPV or condylomata or atypia

  • CIN I/mild dysplasia

  • CIN II/moderate dysplasia

  • CIN III/severe dysplasia

  • In situ cervical cancer

  • Adenocarcinoma in situ of cervix

  • Invasive cervical cancer

  • Other cancer

  • Adenocarcinoma of the cervix

  • Endometrial cancer

  • Vaginal cancer

  • Vulvar cancer

  • Ovarian cancer

  • Cervical polyps

  • Vaginal intraepithelial neoplasm (VAIN)-specify VAIN 1, 2, 3

  • Vulvar intraepithelial neoplasm (VIN)--specify VIN 1, 2, 3

If cervicography performed

Date of cervicography


MM/DD/YYYY

If endometrial sampling performed

Date of endometrial sampling

MM/DD/YYYY

If endometrial sampling performed

Endometrial sampling results

  • Normal or benign reaction or inflammation

  • Squamous metaplasia

  • HPV or condylomata or atypia

  • CIN I/mild dysplasia

  • CIN II/moderate dysplasia

  • CIN III/severe dysplasia

  • In situ cervical cancer

  • Adenocarcinoma in situ of cervix

  • Invasive cervical cancer

  • Other cancer

  • Adenocarcinoma of the cervix

  • Endometrial cancer

  • Vaginal cancer

  • Vulvar cancer

  • Ovarian cancer

  • Cervical polyps

  • Vaginal intraepithelial neoplasm (VAIN)-specify VAIN 1, 2, 3

  • Vulvar intraepithelial neoplasm (VIN)--specify VIN 1, 2, 3

If other test performed

Date of other test

MM/DD/YYYY

If other test performed

Type of test performed





Attachment F. Chart review 4

File Typeapplication/msword
File TitleAppendix C
AuthorBattelle
Last Modified ByBattelle
File Modified2008-07-25
File Created2008-07-25

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