Medical Records Review

Medical Records Review

At the time of study enrollment, patients were asked to give consent for study personnel to access their medical and billing records. These data will provide the information necessary to answer the primary study question, namely does HPV as an adjunct to Pap testing with provider and patient education lead to extended screening intervals for women with negative results. Information will be obtained for a period of 3 years following study enrollment. The information that will be obtained includes (1) type of provider seen during each office visit, (2) date of the visit, (3) whether or not a Pap test was performed, and (4) whether or not the visit was for a wellness checkup.

The chart review will also support the secondary study question of what type of follow-up is received by HPV positive women (i.e., abnormal Pap and/or positive HPV). The variables that will be obtained from medical records 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 E. Medical Records Review 4