Colposcopy: Standards for Technique and Documentation

ASHLYN SAVAGE

Background Hundreds of thousands colposcopies performed every year

Performed by Ob/Gyn, Family Practice, Internists, NPs, PAs

Large country, many remote areas that need coverage but have low

volumes

No nation-wide integrated healthcare system, no screening or precancer registries

Training is highly inconsistent: Residency, courses (e.g. ASCCP), mentorship training, self-education

No formal certificate of colposcopy competence

No formal colposcopy guidelines/ standards

Vignettes…WWYD

24 yo G0 with ASC-H pap smear Repeat pap in 6 months Add HPV testing Colposcopy – if no lesion then no biopsy Colposcopy – If no lesion then ECC and Random bx “See and Treat” Leep

45 yo G4P4 with HSIL Pap that was positive for HPV 16 Colposcopy, if no lesion then ECC Colposcopy, if no lesion then ECC and Random Bx “See and Treat” Leep Refer to GYN Oncology

Let’s describe this Colpo A. Adequate? B. Lesion Present?

A. Character?

B. Borders?

C. Vascular features?

D. Location?

C. Would you biopsy? A. Where?

B. More than one?

D. Colposcopic Impression?

1. Adequate? 2. Lesion Present?

1. Character?

2. Borders?

3. Vascular features?

4. Location?

3. Would you biopsy? 1. Where?

2. More than one?

4. Colposcopic Impression?

IMPROVE-COLPO Study Two-arm study Setting: US community-based clinics offering colposcopy Population: women ≥21 yo referred for colposcopy Pragmatic “real world” practice Active arm: outcomes with DYSIS colposcope (prospective colposcopies) Control arm: standard colposcopy outcomes (retrospective data by chart

review ) IRB-approved, Clinicaltrials.gov: NCT02185599

Outcome measures Detection of CIN2+, number of patients biopsied, number of biopsies

Recruitment to date 44 clinics across 12 states, 160 providers 30 clinics have completed participation >6,800 women recruited across the two arms

IFCPC 2017 World Congress Oral Presentation – Warner Huh

Practice and Population Profile

44 community-based colposcopy clinics Teaching hospitals: 2 Large private clinics (3-15 providers): 24 Small private offices (1-2 providers): 18

160 Providers Obstetrician/Gynecologists, Gynecologic Oncologists Nurse Practitioners, Physician Assistants

Patient characteristics (N=3,404) Median age 34 years old Menopausal: 11.8% 88.3% privately insured Low incidence of CIN2+ disease (13.6% overall) 86% referred from screening with “lesser abnormalities”

Colpo Referral Patterns Referral patterns among women age 21-24

High Grade (N=82)

HSIL, ASC-H, AGC 10.2%

Low Grade (N=704)

LSIL, ASCUS and HPV Cytology Only Had HPV co-test

87.5% 57.4% 30.1%

• Women < 25 are frequently co-tested for HPV • Women < 25 are frequently undergoing colpo for

low grade abnormalities

Approach to Biopsy

Many women undergo ECC

Cervical biopsy is practiced conservatively

# of biopsies per patient

N(%)

None 1036 (30.4%) 1 1547 (42.8%) 2 705 (20.7%) 3 183 (5.4%) 4 22 (0.6%) 5 0 (0%)

Random 28 (0.8%) Avg (Median)

Overall 1.03 (1) High Grade (n=412) 1.48 (1)

Low Grade (N=2926) 0.98 (1)

Age 21-24 25-29 30-55 >55 Total Patients (N)

444 720 1958 254 3404

ECC 266 (59.9%)

517 (71.8%)

1514 (77.3%)

199 (78.3%)

2946 (73.3%)

Documentation and Treatment Colposcopic impression rarely documented

40% of charts note impression

“See and Treat” Leep Rarely Done

Excision at time of colpo for High Grade referral

Age 21-24 25-29 30-34 41-55 > 55 Total

Number 51 102 140 85 34 412

“See and Treat” (n) 1 0 2 2 0 5

Follow up

Follow-up is often recommended at 6 months rather than 12 months

Plan for pap smear follow-up

Histology Result

Interval No result Result = normal

CIN 1 Total

6 months 214 633 413 1260

12 months 123 577 332 1032

ASCCP Colpo Standards Project Four Working Groups:

WG1: Role of colposcopy, benefits, potential harms, and terminology

WG2: Risk based colposcopy practice WG3: Colposcopy procedures and

adjuncts WG4: Quality Control

WG1: Standardize Terminology Simplify and clarify mechanism of colpo documentation across breadth of colposcopists IFCPC terminology was adapted to fit colposcopy practice in the US

WG2: Colposcopy practice can be modified based upon risk assessment and colposcopic impression

If risk of HSIL is very low, more expectant management is appropriate

If risk is intermediate, multiple biopsies leads to increased detection

If risk is high, then immediate treatment is recommended

The Low Risk Patient Biopsy may be deferred if:

Less than HSIL cytology, no known HPV16/18 positivity, and a normal colposcopic impression (i.e. no acetowhitening, metaplasia, or other visible abnormality)

Intermediate Risk Multiple biopsies targeting all areas with aceto-whitening, metaplasia, or other high grade features should be collected.

• At least two, and up to four, biopsies from discrete lesions should be taken.

*a single biopsy targetting the “worst” area may miss up to a 1/3 of prevalent high grade lesions

High Risk Recommend ‘See and Treat’ LEEP in non-pregnant women age >25 with at least two of the following:

HSIL cytology HPV 16 or 18 positivity High grade impression on colposcopy

Rationale for Including Colposcopic Impression in Decision Systemic Review 13 studies / N= 4611 patients

Among women with HSIL pap and high grade colpo impression, 90% confirmed to have high grade disease on LEEP path

Over-treatment rate is about 10% No different that over-treatment rate associated with two step

approach

If HSIL pap and low grade impression, over-treatment rate was 29%

Advantages to See and Treat: better compliance, lower cost, less angst

Ebisch et al. BJOG Jan 2016

WG3: Colposcopy Procedures

Sample Collection

Documentation of Colposcopy

.ascolpo 60 y.o. G2P2 presenting for colposcopy. She has the following complaints today: None Patient Pregnant: {YES/NO:25502} Referral Pap Smear / Date: Pap Smear / Colposcopy History: LMP: Contraception: {GYN CONTRACEPTIVES:27677} Tobacco use: {Tobacco Use:21540} Past Medical History:

COLPOSCOPY PROCEDURE DOCUMENTATION:

PROCEDURE NOTE:

Patient was consented for colposcopy including possible cervical biopsy and endocervical curetting. The vulva was normal in appearance with no evident skin lesions. With the patient in a dorsal lithotomy position, the cervix was visualized with a speculum and noted to have a grossly normal appearance. The cervix and upper vagina were cleansed with dilute acetic acid and visualized with low- power magnification with the colposcope.

Findings:

Colposcopy Adequate: {YES/NO:25502}

Transformation zone seen: {YES/NO:25502}

Endocervical Speculum Needed: {YES/NO:25502}

Lesion Character:

White Epithelium noted: {YES DESCRIBE WITH CLOCK:26717}

Punctation noted: {YES/NO:25502}

Abnormal vessels noted: {YES/NO:25502}

Mosaicism noted: {YES/NO:25502}

Endocervix involved: {YES/NO:25502}

Lugol's Used: {YES/NO:25502}

Specimens collected: Pap: {YES / NO:22259}

Biopsy taken: {YES DESCRIBE WITH CLOCK:26717}

ECC performed: {YES/NO:25502}

Vaginal Biopsy: {YES / NO:22259}

Vulvar biopsy: {YES / NO:22259}

Patient tolerated the procedure well and left the office in stable condition.

COLPOSCOPIC IMPRESSION: : {OBGYN COLPOSCOPY PREDICTION:26716}

If treatment is indicated would recommend:

Patient will follow up {GEN CONTACT METHODS:26718} to discuss results.

WG4: Minimum and Aspirational Quality Measures

Minimum Aspirational Documentation Adequacy Lesion present (yes / no) Colposcopic impression Cervix visibility Extent of lesion Location of lesion

90 90 80 70 70 70

100 100 100 100 100 100

Provider should take multiple biopsies targeting all acetowhite areas (at least 2, up to 4)

85 100

Patient’s with results suggestive of invasive disease she be contacted within two weeks, and should be seen within two weeks of contact

60 90

Patients with results suggestive of high grade disease she be contacted within 4 weeks and seen within 4 weeks of contact

60 90

Summary

Consider a template for you colpo documentation

Biopsy liberally

Consider “See and Treat” LEEP