Thank you for taking the time to review the ASCCP Risk-Based Management Consensus Guidelines preliminary guidance documents (PDF,  1 MB). The following questions were developed by the Consensus Working Groups to collect input and feedback on each section of the guidelines. There are 20 total questions, plus demographic information at the end. You can submit comments on all items or on specific items only. Feedback collected through this public comment period will be reviewed by the Working Groups and used to revise the guidelines and bring them to a final format. If you need to return to add additional comments, click "done" to save your work and come back later (from the same device to avoid duplication of your entry). Comments can be submitted anonymously, or with your name and affiliation. If you run into difficulty, please email info@asccp.org.

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* 1. Would you like to make any general comments about the guidelines? Please note that you can comment specifically on each recommendation below, but general comments are welcome here.

Section 1. Clinical Action Thresholds
Surveillance

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* 2. When patients have an estimated 5-year CIN3+ risk of ≤0.1% based on prior history and current results, return to routine screening at 5-year intervals is recommended.

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* 3. For patients initially diagnosed with low grade cytologic or histologic abnormalities or HPV infections, that have had three negative consecutive HPV-based tests: should the new guidelines recommend returning patients to routine screening at 5-year intervals?

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* 4. When patients have an estimated 5-year CIN3+ risk above 0.1% but below 0.5% based on prior history and current results, repeat testing in three years with HPV-based testing is recommended

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* 5. For patients whose estimated risk of CIN3+ risk based on prior history and current results is below the threshold for immediate colposcopy (4% immediate risk) and above the 3 year follow-up threshold (0.5% at 5 years), repeat testing in one year with HPV-based testing is recommended.

Colposcopy

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* 6. When individuals have an estimated immediate risk of diagnosis of CIN3+ of 4.0% or greater based on prior history and current results, referral to colposcopy is recommended.

Treatment

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* 7. For patients with an estimated immediate risk of CIN3+ of greater than or equal to 50% based on prior history and current results, treatment using an excisional procedure without prior biopsy confirmation (see-and-treat) is preferred. Treatment after colposcopy and biopsy confirmation of HSIL(CIN2+) is acceptable.

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* 8. For patients with an estimated immediate risk of CIN3+ greater than or equal to 25% based on prior history and current results, treatment using an excisional procedure without prior biopsy confirmation (see-and-treat) or treatment after colposcopy and biopsy confirmation of histologic HSIL(CIN2+) are both acceptable.

Section 2. Risk Modification and Special Populations

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* 9. Recommendations for managing abnormal test results in pregnant patients.

Management guidelines for pregnant individuals were considered, and literature published since 2012 was reviewed. However, data in pregnancy are limited, and given the unique implications for the mother and the pregnancy shared clinical decision-making is critical for management decisions.

Pregnancy does not appear to alter the risk for or rate of progression from cervical pre-cancer to cancer, and colposcopy-directed biopsies in pregnant patients appears safe. Based on the new threshold criteria, among well-screened populations, fewer individuals will be referred to colposcopy and those referred will be at higher risk of immediate CIN3+ due to persistent HPV infections or prior HSIL (CIN2/3). Therefore, in pregnancy, management of abnormal screening results using the same risk thresholds established for non-pregnant individuals is recommended. Management should include limiting the number of biopsies.1 Endocervical curettage and endometrial biopsy are unacceptable in pregnancy. If a patient has a suspected cancer by cytology or colposcopic impression, adequate biopsies to obtain sufficient tissue are recommended. Treatment is not recommended unless cancer is pathologically confirmed.

If treatment is deferred for a pregnant patient who otherwise would have been treated (e.g. HSIL/CIN2/3/AIS), surveillance colposcopy and testing (diagnostic cytology/HPV) in pregnancy is recommended every 12-20 weeks with intent for treatment postpartum. Repeat biopsy is only recommended if the appearance of the lesion or the cytology worsens. In the postpartum period, the treatment procedure or a full diagnostic evaluation (cervical cytology, HPV, colposcopy and biopsy) is recommended no later than 16 weeks but no earlier than four weeks postpartum.

1 Since bleeding is commonly associated with biopsies in pregnancy, limiting the number of biopsies should be considered, specifically if the referral was for less than HSIL and the colposcopic impression is low grade. 

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* 10. Recommendations for managing abnormal test results in immunocompromised patients. Management of abnormal screening results using the same risk thresholds established for the general screening population is recommended except for those less than 25 years of age. Immediate referral to colposcopy is recommended for all abnormal results, including ASCUS HPV- and LSIL HPV-, even in those under 25 years of age.

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* 11. Recommendations about not including data on the following factors in risk estimates: hormonal contraception, history of sexually transmitted infection, multiparity, cigarette smoking, obesity, HPV vaccination status.

Section 3. Statement Regarding Lower Anogenital Squamous Terminology (LAST)
It is important to use p16 immunohistochemical (IHC) staining according to the guidance provided by the CAP-ASCCP LAST Project. p16 IHC should be used for specific indications as recommended by LAST when interpreting the H&E slide. A positive p16 immunostain supports the diagnosis of HSIL if the morphological assessment of H&E slides is consistent with CIN2 or CIN3. There is a risk of overcalling cervical histology results when p16 is used incorrectly. Most importantly, a morphologic CIN1 on H&E should not be upgraded to HSIL(CIN2) even if p16 positive.

For epidemiologic and clinical management purposes, it is strongly recommended to qualify an HSIL result by –CIN2 or –CIN3, according to the options given by the LAST guidelines. This qualification can have clinical importance, e.g. when deciding about conservative management of CIN2. It is also important for post-vaccine surveillance studies and quality control assessments of cervical precancer that have relied on CIN2 and CIN3 endpoints. Further, it is important for future research efforts to qualify HSIL –CIN2/ -CIN3 to make endpoints compatible with the histologic endpoints used for current guidelines.

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* 12. How do you feel about this statement?

Section 4. Management of HSIL(CIN2/3), optimized detection, and subsequent management

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* 13. Improving detection of histologic HSIL(CIN2/3) in the setting of primary HPV screening: When primary HPV screening is used, reflex cervical cytology (Pap) testing of all positive HPV tests (including HPV 16/18) is preferred. If reflex cervical cytology testing is not possible, direct referral for colposcopy is acceptable. If cervical cytology is not performed prior to the colposcopy, collection of a cervical cytology specimen at the colposcopy visit is recommended.

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* 14. Treatment guidance - General Population: For individuals with a diagnosis of histologic HSIL (CIN 2, CIN 3, or CIN 2,3) and colposcopy where the squamocolumnar junction is visualized, excision is preferred but ablation is acceptable, except in those that are pregnant, under age 25, or who desire future reproductive potential (see guideline below). A diagnostic excisional procedure is recommended for those with recurrent histologic HSIL (CIN 2, CIN 3, or CIN 2,3). Ablation is unacceptable, and a diagnostic excisional procedure is recommended for individuals with a histologic diagnosis of HSIL (CIN 2, CIN 3, or CIN 2,3) and colposcopy where the squamocolumnar junction is not fully visualized, or endocervical sampling showing HSIL (CIN 2, CIN 3, CIN 2,3), or CIN not graded. Hysterectomy is unacceptable as primary therapy for histologic HSIL (CIN 2, CIN 3, or CIN 2,3).

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* 15. Treatment guidance - Individuals under age 25 or who desire future reproductive potential: For individuals under age 25 or those with desire for future reproductive potential, with a histologic diagnosis of HSIL (CIN2) specified, observation is preferred but treatment is acceptable; treatment is recommended if CIN 3 is specified. For a histologic diagnosis of HSIL (CIN 2/3) in those under age 25 or those desiring future reproductive potential, either treatment or observation for up to 24 months using cytology and colposcopy at 6 months intervals is acceptable, provided the squamocolumnar junction is fully visible and there is no HSIL in the endocervical sampling. If during surveillance cytology and colposcopy are both normal on two occasions, six months apart, subsequent surveillance should be a co-test 12 months after the last colposcopy. If histologic HSIL fails to resolve over a 2- year period, treatment is recommended.

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* 16. Treatment Modalities: Excisional therapy is the preferred therapy for treatment of patients diagnosed with or at high risk for HSIL(CIN2/3) in the United States. Ablation is acceptable after shared decision-making between the patient and a provider trained in ablative techniques, and consideration of risks and benefits.

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* 17. Initial surveillance following treatment: Following treatment for HSIL (CIN2+), HPV-based testing at 6 months is preferred regardless of margin status of the excisional specimen. In the setting of positive margins, repeat excision without interval cytology or HPV testing is acceptable, except in those under 25 years of age and those who desire future reproductive potential. Hysterectomy or continued observation with cytology and colposcopy at 6 months intervals is acceptable for patients whose excisional specimens have positive margins and for whom a repeat excisional procedure is not feasible, or for those who have recurrent HSIL (CIN2+) and/or persistent HPV+ tests despite excisional treatment.

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* 18. Long term surveillance following treatment: In patients treated for HSIL (CIN2/3), following the initial HPV-based test at six months, annual HPV-based testing is preferred until three consecutive negative tests have been obtained. Continued surveillance at 3-year intervals is recommended for at least 25 years following treatment of HSIL (CIN2/3) as well as AIS.2  When individuals with a history of treated HSIL(CIN2/3) or AIS reach the age of 65 years, continued surveillance at 3-year intervals is acceptable as long as they are in reasonably good health. Discontinuation of screening is recommended if they have a life-limiting condition. Management according to the highest grade abnormality found on histology, cytology, and/or HPV type (e.g. HPV 16/18+) is recommended.

2 For management of vaginal cytology following HSIL, see Khan et al Gynecologic Oncology, 2016

General Comments

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* 19. What additional evidence or viewpoints do you believe should have been considered?

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* 20. What information, if any, was missing in these preliminary guidelines?

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* 21. The new guidelines will be available in electronic format, such as a SmartPhone Application and/or website. A no cost version will be available. What additional resources or tools could the working group provide that would make the guidelines more useful to you in its final form?

Demographics Questions

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* 22. Please select the category best identifies your role/expertise

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* 23. What is your training?

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* 24. What is your specialty?

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* 25. Please indicate Practice Type: [academic, community, hospital, private practice]

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* 26. If you wish, you can enter your name, affiliation, and email.

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* 27. If you would like to provide additional feedback, please upload a document here or send to info@asccp.org. Please adhere to the following guidelines:
  • Your comments should be no more than 15 pages single spaced, including all tables, figures, and appendices.
  • Use 11 point font size or higher; this includes the font for all tables, figures, and appendices.
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Written comments must be received by the comment period closing date in order to be considered.

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