Health Systems Approach to Referral and Treatment

Health Systems Approach to Referral and Treatment John Sellors, MD, MSc Durres, Albania March 13, 2004 Overview • Referral and treatment systems • Diagnosis and treatment of cervical precancer • Monitoring and information systems 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. 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 Screening within a Health Care System Screening test Community participation (+) Repeat Periodically? (-) Colpo confirmation Follow-up Treatment (+) An Effective Screening Test Is Only One Part of a Successful Program Community Education Coverage Treatment Screening Test Follow-up 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 Referral Service Models for Colposcopy and Treatment 1. Integrated, vertical or mixed. 2. Single or multiple visit. 3. Static or mobile. Management Options After a Positive Screening Test Screening (+) Referral (+) (+) Colposcopy + Biopsy + Immediate treatment (‘See & Treat’) Colposcopy + Biopsy Treatment of Biopsy Positives 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. 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. Colposcopy • 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. 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 Diagram of the Transformation Zone Transformation Zone Most Distal Cervical Crypt Opening SCJ { Area of Ectopy New Squamocolumnar Junction (SCJ) Location of Squamocolumnar Junction and Transformation Zone Sq. Epi New SCJ Col. Epi TZ Original SCJ Original SCJ TZ Original SCJ New SCJ Original SCJ In Childhood In Post-menopausal In Post-adolescent Women Women SCJ – Squamocolumnar junction Sq. Epi - Squamous epithelium TZ - Transformation zone Col. Epi - Columnar epithelium In Adolescence Illustration: Mrs. S. Sankaranarayanan Squamocolumnar Junction 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. The Two Main Questions when Performing Colposcopy... • Is the examination ADEQUATE? • Can I rule out CANCER? 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. Primary Responsibility of the Colposcopist: Diagnose Cancer At increased risk of cervical cancer: • older age • larger lesion • higher grade cytology A ‘Normal’ Cervix on Colposcopy • Transformation zone is normal AND • Ectocervix is normal AND • Endocervix is normal Transformation Zone Most Distal Cervical Crypt Opening SCJ Area of Ectopy Vascular Atypia a) fine punctation b) mosaicism c) coarse punctation ATZ Border 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 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 Scoring Colposcopy Findings (Modified Reid’s Index) Feature Color Margin Vessels 0 point faint or mild A-W indistinct, feathery fine mosaic, punct’n. 1 point moderate A-W straight, smooth absent 2 points dense or dull A-W peeling or int. border coarse mosaic, punct’n Reid’s Index versus Color for the Detection of High Grade CIN (n=301) 100% 80% 60% 40% 20% 0% Colour Reid's (0); (0-2); n=129 n=174 Colour Reid's (1); (3-4); n=140 n=107 40 59 71 62 28 18 CIN 2/3 Neg/CIN 1 89 115 69 45 4 2 Colour Reid's (2); (5-6); n=32 n=20 Shaw et al. J Lower Gen Tract Dis, 2003 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. 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. Treatment Methods for Cervical Precancer Outpatient: • Cryotherapy • Loop electrosurgical excision procedure (LEEP, LLETZ) Hospital Inpatient: • Cold knife Conization • Hysterectomy Referral Networks Indications Screening-positive Services Colposcopy Level of facility Any CIN Treatment •Cryotherapy •LEEP, Knife Cone, Hysterectomy Any Secondary and Tertiary Cervical Cancer Colposcopy, Staging, Surgery, Radiotherapy, Chemotherapy, Palliative Care Secondary and Tertiary Major Complication Surgical control of bleeding, Blood transfusion, Treatment of Severe Infection Secondary and Tertiary Adapted from Service Program Guide, ACCP 2004 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. 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. 10 1 2 7 3 5 4 6 8 9 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 Cryotherapy equipment components Expected Side Effects of Cryotherapy • Mild cramping • Profuse, watery vaginal discharge for about 1 month • Spotting, light bleeding for 1-2 weeks 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 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) 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 Berget ‘87) (Kwikkel, ‘85; Safety/Complications* Best Evidence (40 papers) • PID - < 1% (Mitchell, ‘98; Berget, ‘87), higher in adolescents (~10%) • Severe Bleeding - none reported • Necrotic plug syndrome - <3% (Mitchell, ‘98; Kwikkel, ‘85; Townsend, ‘83; Berget, ‘87) (Schantz, ‘84; Berget, ‘87; Creasman, ‘73); suspect this is due to endocervical canal freezing-not recommended *<1 month 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 Effectiveness - %Cure Rates Colposcopy + cytology @ 1 year + histologic confirmation Double Freeze CIN 1 90.9 CIN 2 90.9 96.9 85.7 CIN 3 86.4 80.8 78.5 Berget, ‘91 Olatunbosun, ‘92 83.3 Tangtrakul, ‘83 88.9 Cure Rates - Other Factors • Lesion size, age - no evidence • Time to detection of failure (cumulative%) 1 yr 61.7 2 yr 74.0 3 yr 81.5 4yr 91.4 5 yr 100 (Benedet, ‘87) • by ECC: + 50.0% - 82.2% (Ferenczy, ‘85) Overview Conclusions • Cryotherapy ~ 90% effective for ectocervical CIN lesions • Acceptability • vasomotor, spotting <25% • pain, discharge - universal • Safety - PID < 1%, Necrotic plug < 3% • Long term sequelae - poor evidence LEEP/LLETZ LEEP—Loop Electrosurgical Excision Procedure • sometimes referred to as LLETZ — Large Loop Excision of the Transformation Zone 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. 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. Loop Electrosurgical Excision Procedure (LEEP) of an Ectocervical Lesion With One Pass Illustration: Electrosurgery for HPV-related Diseases of the Lower Genital Tract, 1992 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. 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. Cone Biopsy Cone Biopsy Cone Biopsy • Useful to see if microinvasive cancer is present – if so, it can be treated with just a hysterectomy. • Also used to examine the tissue in the endocervical canal if there is concern about disease there. Cone Biopsy Possible Serious Side Effects • Bleeding • Infection Cone Biopsy Possible Sequelae • Most women can have a normal pregnancy and delivery after cone biopsy. • In rare cases, cone biopsy can cause problems with subsequent pregnancies - spontaneous miscarriage or a long labor due to cervical stenosis. Hysterectomy • Done in the hospital and requires general anesthesia. • Usually done for cancer that has not spread beyond the cervix. • If no other indication and outpatient treatment is available, not necessary for treatment of cervical precancer. Danforth’s Obstetrics & Gynecology, 6th edition Hysterectomy Hysterectomy Possible Side Effects • Bleeding, infection, accidental injury to other organs, such as the bowel or bladder. • Ovaries may also be removed, creating a menopausal state. Goal of a Cervical Cancer Prevention Program To reduce the incidence, morbidity and mortality from cervical cancer. Data Requirements for Program Evaluation • Population of interest (population register or census) • Register of screening tests (cytology labs) • Follow up on positive tests (colposcopy clinics and histopathology labs) • Invasive cervical cancers (cancer registry) • Deaths from cervical cancer (vital statistics) Adapted from Miller AB. Cervical Cancer Screening Programs: Managerial Guidelines, WHO 1992 Model of an Information & Reporting System* Cytology Labs •Identifiers •Personal data •Smear data •Health Centers •Cytology Labs Histopathology Labs •Identifiers •Biopsy/treatment data Editing & Linkage Cervical Screening Database •Histopath. Labs •Screening & Treatment Program Colposcopy/Treatment Center •Identifiers •Colpo Diagnosis •Treatment Population Database *adapted from Marett L. Cancer Care Ontario, 2001 Periodic Linkages with Ext Databases •Government •Researchers Cancer Registry Mortality File Hospital Data •hysterectomies Core Indicators for Program Evaluation 1. Coverage (% of population of interest screened) 2. Follow up of positive tests 3. Inadequate rate of cytology 4. Histopathology-cytology agreement 5. Performance testing Core Indicator - Coverage • Screening data from all cytology labs which are linked to give woman-specific information. • Population register. Core Indicator – Follow up of Test-Positives • Screening data on all positives. • Colposcopy clinic data for all visits. • Screening test and colposcopy data linked to provide woman-specific information. Can You Suggest an Approach for the Other Core Indicators? • Inadequate rate of cytology. • Histopathology-cytology agreement. • Performance testing – example QC for colposcopists; Cryotherapy; LEEP. Data for Continuous Program Monitoring • • Data quality is preferable to quantity Only collect essential data that will be used. Indicators and Corrective Actions Program Goal Attract women Components Appropriate age group Indicators Correctives Age distribution Train staff, not consistent revise strategy Limiting rescreening Screen with good test Test quality High rate Inadequate rate high Improve message Retraining of cytotechs Ensure appropriate treatment Treatment of test-positives Low rate treated in 3 mo Improve counseling, tracking Sources of Clinical Care Data Screening, Referral, Recall • Cytology lab records • Screening clinic records Colposcopy, Diagnosis, Treatment, Recall • Colposcopy clinic records • Histopathology lab records Communication of Results and Recall • Effective information and outreach systems ensure that patients receive test results, periodic screening and appropriate followup after treatment. • Women who have negative screening results should come for periodic repeat screening. Record of Screening • Screening provider should keep a register of each smear sent to lab, test result, communication with client. • Medicolegal implications. Record of Referral Visit • Colposcopist should keep a register of each client seen; final diagnosis; communication with client. • Medicolegal implications. Recall – ‘Tickler’ System • A simple card file, organized by month and year, can be set up in any clinic to serve as a reminder for the recall of patients for follow-up visits or screening visits. John Sellors, MD, MSc Senior Medical Advisor Reproductive Health jsellors@path.org 206.285.3500 www.path.org