Att F_Chart Review Plan_0209

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