Health Systems Approach to Referral and Treatment

1. Health Systems Approach to Referral and Treatment John Sellors, MD, MSc Durres, Albania March 13, 2004

2. Overview • Referral and treatment systems • Diagnosis and treatment of cervical precancer • Monitoring and information systems

3. Cervical Cancer Screening • Since most sexually active women have already been infected, all are at risk. • Early identification and treatment of precancerous lesions (CIN) are the immediate needs. • Screening for early detection and treatment is essential.

4. Screening Methods - 2004 • Cytology* • Conventional cytology • Liquid-based cytology • Alternatives to Cytology • Visual Inspection with Acetic Acid (VIA) • Visual Inspection with Lugol’s Iodine (VILI) * With or without HPV DNA test for oncogenic types

5. Screening within a Health Care System Screening test Community participation (+) (-) Repeat Periodically? Colpo confirmation (+) Follow-up Treatment

6. Community Education Treatment Coverage Screening Test Follow-up An Effective Screening Test Is Only One Part of a Successful Program

7. Three Main Cervical Cancer Prevention Objectives* • Encourage participation of women. • Screen with a high quality test. • Use effective and efficient treatment. *Robles S. PAHO, 2003

8. Referral Service Models for Colposcopy and Treatment • Integrated, vertical or mixed. • Single or multiple visit. • Static or mobile.

9. Screening (+) Referral (+) (+) Colposcopy + Biopsy Colposcopy + Biopsy + Immediate treatment (‘See & Treat’) Treatment of Biopsy Positives Management Options After a Positive Screening Test

10. Indications for Colposcopy Referral • High grade abnormality on cytology. • Persistent low grade or inadequate cytology. • AGUS (Atypical Glandular Cells of Undetermined Significance) cytology. • Suspicious looking cervix on visual examination.

11. Exchange of Information is Important for Optimal Care • Letter with reason for referral from screening provider to colposcopist. • Feedback on diagnosis from colposcopist to screening provider.

12. A diagnostic test that confirms microscopic visual findings with a directed biopsy. Permanent record possible with drawing of the findings or a photograph. Can be done at any level of the health care system, usually by a physician. Colposcopy

13. Essential Tools for Colposcopy • 6 to 16 x magnif’n. • Strong variable light • 250 mm focal distance for instruments • Solutions: • normal saline • 3-5% acetic acid • Lugol’s iodine

14. Diagram of the Transformation Zone Most Distal Cervical Crypt Opening Transformation Zone SCJ { Area of Ectopy

15. New Squamocolumnar Junction (SCJ)

16. Location of Squamocolumnar Junction and Transformation Zone Sq. Epi New SCJ Col. Epi TZ New SCJ TZ Original SCJ Original SCJ Original SCJ Original SCJ In Post-menopausal Women In Post-adolescent Women In Childhood In Adolescence SCJ – Squamocolumnar junction Sq. Epi - Squamous epithelium TZ - Transformation zone Col. Epi - Columnar epithelium Illustration: Mrs. S. Sankaranarayanan

17. Squamocolumnar Junction

18. Colposcopy Procedure • Wash the cervix with a 3-5% acetic acid solution. • Inspect the cervix under magnification (4X to 20X). • Assess the entire TZ and any acetowhite areas; take a biopsy of any abnormalities.

19. The Two Main Questions when Performing Colposcopy... • Is the examination ADEQUATE? • Can I rule out CANCER?

20. If Colposcopy is Inadequate Providing woman is not pregnant, always sample the endocervical canal (endocervical curettage or cytobrush cytology) when SCJ is not completely seen.

21. Primary Responsibility of the Colposcopist: Diagnose Cancer At increased risk of cervical cancer: • older age • larger lesion • higher grade cytology

22. A ‘Normal’ Cervix on Colposcopy • Transformation zone is normal AND • Ectocervix is normal AND • Endocervix is normal

23. Most Distal Cervical Crypt Opening Transformation Zone SCJ Area of Ectopy Vascular Atypia a) fine punctation b) mosaicism c) coarse punctation ATZ Border

24. Common Colposcopy Pitfalls... • Failure to biopsy. • Failure to use an endocervical speculum to see SCJ. • Failure to do ECC if entire SCJ not seen. • Failure to record findings. Adapted from Soutter

25. More Common Colposcopy Pitfalls... • Failure to communicate with pathologist. • Failure to later correlate histology with colposcopy. • Failure to perform self-auditing for QC. Adapted from Soutter

26. Scoring Colposcopy Findings (Modified Reid’s Index)

27. Reid’s Index versus Color for the Detection of High Grade CIN (n=301) Shaw et al. J Lower Gen Tract Dis, 2003

28. Colposcopy Documentation • Patient identification, personal data. • Contact information. • Reason for referral. • Description (Reid’s Index) and drawing of cervical findings showing biopsy site. • Colposcopic, histologic and cytologic findings. • Final diagnosis and management plan.

29. Purposes Served by Clinic Documentation • Copy sent to referral source. • Aide memoire for clinical care and management plan. • QC of colposcopy skills (histology correlation). • Medicolegal record.

30. Treatment Methods for Cervical Precancer Outpatient: • Cryotherapy • Loop electrosurgical excision procedure (LEEP, LLETZ) Hospital Inpatient: • Cold knife Conization • Hysterectomy

31. Referral Networks Adapted from Service Program Guide, ACCP 2004

32. Cryotherapy • May be done at any level of health care system by trained nurse or physician. • The procedure is simple and low-cost. • 80-90%% effective in treating even high-grade precancerous lesions. • Suitable lesions: covered by probe and not involving the canal.

33. Cryotherapy Procedure • Rule out pregnancy. • A metal probe that is cooled by a refrigerant gas (CO2 or N2O) is placed on the ectocervix. • The area is frozen for ~3 min, thawed 5 min, and frozen for ~3 min again.

34. 1. Probe 2. Trigger 3. Handle grip (fiberglass) 4. Yoke 5. Instrument inlet of gas from cylinder 6. Tightening knob 7. Pressure gauge showing cylinder pressure 8. Silencer (outlet) 9. Gas-conveying tube 10. Probe tip 10 1 2 7 3 5 9 4 8 6 Cryotherapy equipment components

35. Expected Side Effects of Cryotherapy • Mild cramping • Profuse, watery vaginal discharge for about 1 month • Spotting, light bleeding for 1-2 weeks

36. Cryotherapy Overview* • Systematic overview of the literature • Definitions (acceptability, safety, effectiveness, long term sequelae) • Evidence for each outcome • Other issues (lesion size & grade, age, low resource setting) *ACCP publication, 2003

37. Definitions • Acceptability - side effects @ <1 month (pain, vasomotor, discharge, spotting) • Safety - complications @ <1 month (PID, bleeding, necrotic plug) • Effectiveness - (lesion-free @ >1 year) • Long term sequelae - problems after 1 month (stenosis, infertility, obstetrical problems)

38. Acceptability - Best Evidence(43 papers) • Vasomotor - 10 to 20% (Townsend ‘71, ‘83) • Pain - < labor, ~4 (scale of 0 to 10) (Sammarco ‘ 93, Harper ‘97) • Discharge - ~ universal, 1/3 malodorous, usually < 1 month (Berget ‘87) • Spotting - < 1/4, ~3 days (Kwikkel, ‘85; Berget ‘87)

39. Safety/Complications*Best Evidence (40 papers) • PID - < 1% (Mitchell, ‘98; Berget, ‘87), higher in adolescents (~10%) • Severe Bleeding - none reported (Mitchell, ‘98; Kwikkel, ‘85; Townsend, ‘83; Berget, ‘87) • Necrotic plug syndrome - <3% (Schantz, ‘84; Berget, ‘87; Creasman, ‘73); suspect this is due to endocervical canal freezing-not recommended *<1 month

40. Sequelae*Best Evidence(32 papers) • Stenosis - < 2% ‘needed’ dilation in the clinic (Mitchell, ‘98) • Obstetrical problems - all low powered comparative studies & no differences in rapid labor, C-S, abortion rates (Benrubi, ‘84; Hemmingsson, ‘82) • Infertility - no valid studies *> 1 month after treatment

41. Effectiveness - %Cure Rates Colposcopy + cytology @ 1 year + histologic confirmation Double FreezeCIN 1 CIN 2 CIN 3 Berget, ‘91 90.9 90.9 86.4 Olatunbosun, ‘92 83.3 96.9 80.8 Tangtrakul, ‘83 88.9 85.7 78.5

42. Cure Rates - Other Factors • Lesion size, age - no evidence • Time to detection of failure (cumulative%) 1 yr 2 yr 3 yr 4yr 5 yr 61.7 74.0 81.5 91.4 100 (Benedet, ‘87) • by ECC: + 50.0% - 82.2% (Ferenczy, ‘85)

43. Overview Conclusions • Cryotherapy ~ 90% effective for ectocervicalCIN lesions • Acceptability • vasomotor, spotting <25% • pain, discharge - universal • Safety - PID < 1%, Necrotic plug < 3% • Long term sequelae - poor evidence

44. LEEP/LLETZ LEEP—Loop Electrosurgical Excision Procedure • sometimes referred to as LLETZ —Large Loop Excision of the Transformation Zone

45. What Is LEEP/LLETZ? • An excisional method, using a thin electric wire to remove the entire TZ and therefore removes the affected tissue. • This is a key feature of LEEP - it removes tissue which can be examined further, rather than destroying the tissue by freezing.

46. What Is LEEP/LLETZ? • Requires more equipment, including an electricity source, a smoke evacuator, and local anesthetic. • 90% effective in treating women for precancerous lesions the first time used. • More side effects for the patient. • Relatively higher cost.

47. Loop Electrosurgical Excision Procedure (LEEP) of an Ectocervical Lesion With One Pass Illustration: Electrosurgery for HPV-related Diseases of the Lower Genital Tract, 1992

48. LEEP—Adverse Effects • Possible side effects of LEEP are similar to cryotherapy, but chance of severe bleeding is slightly higher. • Less than 2% of women have moderate to severe post procedure bleeding. • Women may have a brown or black discharge for up to two weeks after LEEP.

49. Cone Biopsy • Done under general anesthesia in the hospital by a gynecologist. • Cone biopsy removes the entire circumference of the transformation zone and most of the cervical canal. • If outpatient treatment appropriate and available, conization is not necessary for treatment of cervical precancer.

50. Cone Biopsy