Development of A Management Guideline Wheel for Abnormal Pap Smears and Related Cervical Pathology

ACOG: American College of Obstetricians and Gynecologists; USPSTF: United States Preventive Services Task Force; ACS American Cancer Society; ASCCP: American Society for Colposcopy and Cervical Pathology; ASCP: American Society for Clinical Pathology; CDC: Centers for Disease Control and Prevention; ACP: American College of Physicians; NICE: National Institute for Health and Care Excellence; NHS: National Health Service; VIA: Visual Inspection with Acetic Acid; HPV: Human Papillomavirus; ASCUS: Atypical Squamous Cells of Undetermined Signifi cance; LSIL: Low Grade Squamous Intraepithelial Lesion; HSIL: High Grade Squamous Intraepithelial Lesion; ASC-H: Atypical Squamous Cells in which HSIL cannot be excluded; AGC: Atypical Glandular Cells; AIS: Adenocarcinoma In Situ; CIN: Cervical Intraepithelial Neoplasia; SCC: Squamous Cell Carcinoma; LLETZ: Large Loop Excision of the Transformation Zone; CKC: Cold Knife Conization


Repeat Pap Smear, either
3. Abnormal Pap Smear with Abnormal Squamous Cells.
3. Presence of Specifi c micro-organism, the wheel determines the management in Two Steps: Step 1 → (1A) →1A Treat infection (with the specifi c antimicrobial agents).
3. Second Smear becomes Unsatisfactory, the wheel determines the management in Two Steps: Step 1 → (1A) →1A Treat infection (with the specifi c antimicrobial agents).
5. Presence of Endometrial cells, the wheel determines the management in Two Steps: Step 1 → (1A) →1A Refer to Gynaecologist.
3. Total Hysterectomy with not known histopathology or abnormal Pap Smear, the wheel determines management in Two steps: Step Step 1 → (1&B) →1&B Repeat Smear of the Vault Yearly for fi ve years.

Total Hysterectomy with past history of CIN (Margin Not
Free), the wheel determines management in One step: Step 1 → (1AB) →1AB Repeat Smear of the Vault in 3-6 months +then Yearly .
6. Hysterectomy in immune suppressed women, the wheel determines management in One step: Step 1 → (1B) →1B the Wheel determines the management in Three steps:
2. CIN1 on Biopsy in women with HPV Negative or Positive with low risk HPV and patient is compliant (Persistent), the Wheel determines the management in Four steps: Step 1 → (1AB)→ Colposcopy ECC +Directed Biopsy.

CIN1 on Biopsy in women with HPV Negative or
Positive with low risk HPV and Patient is compliant (Progression), the wheel determines the management in One step: Step 1 → (1AB) →1AB Refer to Gynaecologist+Oncologist.

CIN1 on Biopsy in women with HPV Positive with High
risk HPV and patient is not compliant (Persistent), the wheel determines the management in Four steps: Step 1 → (1AB) → Directed Therapy Ablation, Excision.
Step 2 → (2) → 2 Total Hysterectomy 1. Management of invasive Adenocarcinoma on Biopsy, the wheel determines management in One step: Step 1 →1B → Guidelines for Cervical Cancer.

Management of Non-invasive Adenocarcinoma on Biopsy
Margin Not Free, the wheel determines management in One step: Step 1 →1®C -1→ Directed Therapy Re-Conization or Total Hysterectomy.

Management of Non-invasive Adenocarcinoma on Biopsy
Margin Free Fertility Desired, the wheel determines management in One step: Step 1 →1ABC -1→ Directed Therapy Ablation, Excision, Conization or Total Hysterectomy.

Management of Non-invasive Adenocarcinoma on Biopsy
Margin Free Fertility Not Desired, the wheel determines management in One step: Step Step 1 → (1) → 1 Repeat Pap Smear.
Step 3 → We have compared and evaluated this extensive list of Guidelines in a research paper that has been submitted for publication. As we have described how the recommendations and the wheel were developed, we will now describe how to use the wheel. This Wheel suggests ten action steps in the journey for the managing of abnormal cervical cytology and precancerous lesions: 1. Routine Screening Schedule (according to the program and guideline of the country or the institute). is to perform HPV co-testing after 12 months plus referral for colposcopy [1][2][3][4][5]. For women who have a history of CIN 2 or higher and/or have undergone a total or supra-cervical hysterectomy, the ACOG recommends screening by cytology every 3 years for a total of 20 years after the initial posttreatment surveillance period [1][2][3][4][5].

Reviewing screening guidlines for the prevention and early detection of cervical cancer
The (1) For CIN lesions: CIN 1 lesions should be followed up with a cytological smear with or without colposcopy at 12 months.
The patient can decide whether to start treatment initially or watch and wait to treat only if no regression occurs within 24 months. CIN2 or CIN3 lesions will be treated with ablation or large loop excision of the transformation zone [6].

Guidelines by the Society Of Obstetricians And Gynecologists Of
Canada has focused more on the use of biopsies. They state that borderline changes such as ASCUS or mild dyskaryosis such as LSIL on cytology should fi rst be followed up with colposcopy screening results (10). The guidelines highlight HPV testing as a more superior screening tool than cytology, however, algorithms are provided for both methods [8][9][10][11][12][13].
If the HPV test is negative, repeat screening every 5years.
If the test is positive, perform VIA to assess eligibility for treatment with cyotherapy and to exclude cervical cancer. If the VIA is negative, repeat screening in 1-year and then every  [8][9][10][11][12]14].

The European Guidelines for Quality Assurance In Cervical Cancer
Screening support that the use of HPV testing alone is better than cytology as a screening test for cervical cancer. They have also drawn the conclusion that co-testing catalyzes fi nancial costs and referrals to colposcopy. However, these fi ndings could only be found in patients between the ages of 30-65. Cytology remains the primary screening tool for those beyond this age range [15]. Lengths of follow up are specifi ed in the guidelines according to initial HPV testing and cytology results. If the HPV test is negative, it should be repeated at least every 5 years. For HPV positive tests, cytology will be done on the same sample collected. If the results come back negative, the test will be repeated in 6-12 months. If cytology indicates ASC-H, HSIL or AIS, the patient requires immediate referral to colposcopy. If cytology indicates ASCUS, AGC or LSIL, the patient can either repeat the test in 6-12 months' time or be referred to colposcopy [15].

Acknowledgement
The guideline for management of abnormal cervical cytology/pathology presented as a Flow Chart and this Wheel were developed by Professor M Samy Ismail, Department of Gynaecology, King Hamad University Hospital (KHUH), Kingdom of Bahrain.
The idea of this wheel was inspired by the WHO Medical Eligibility Criteria for Contraceptive Use, 5 th edition (2015) (MEC Wheel). The MEC Wheel is an evidence-based guideline that was developed for providers involved in family planning to recommend safe and effective contraceptive methods for women with medically relevant characteristics or certain medical conditions. Thomas Vaidyan P.K. and Fouad Ismail for helping in the design of the wheel and implementation of the ideas. any other quality indicators, e.g., partially obscuring blood, infl ammation, etc.).
Specimen processed and examined, but unsatisfactory for evaluation of epithelial abnormality because of (specify reason).

General Categorization (optional)
• Negative for Intraepithelial Lesion or Malignancy • Other: e.g., endometrial cells in a woman 45 years of age.
• Epithelial Cell Abnormality: Specify 'squamous' or 'glandular' as appropriate) • Negative for intraepithelial lesion or malignancy: When there is no cellular evidence of neoplasia.