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 Lugols 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
()
Treatment
Follow-up
6
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
Management Options After a Positive Screening Test
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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
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.

13
Essential Tools for Colposcopy

• 6 to 16 x magnifn.
• Strong variable light
• 250 mm focal distance for instruments
• Solutions
• normal saline
• 3-5 acetic acid
• Lugols iodine

14
Diagram of the Transformation Zone
Most Distal Cervical Crypt Opening
Transformation Zone
SCJ

Area of Ectopy
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Squamocolumnar Junction (SCJ)
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Location of Squamocolumnar Junction and
Transformation Zone
SCJ Squamocolumnar junction Sq. Epi - Squamous
epithelium TZ - Transformation zone Col. Epi -
Columnar epithelium
Illustration Mrs. S. Sankaranarayanan
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Squamocolumnar Junction
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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?

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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.

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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

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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 Reids
Index)
27
Reids Index versus Color for the Detection of
High Grade CIN
(n301)
Shaw et al. J Lower Gen Tract Dis, 2003
28
Colposcopy Documentation

• Patient identification, personal data.
• Contact information.
• Reason for referral.
• Description (Reids 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

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Referral Networks
Adapted from Service Program Guide, ACCP 2004
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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.

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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.

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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 _at_ lt1 month (pain,
  vasomotor, discharge, spotting)
• Safety - complications _at_ lt1 month (PID, bleeding,
  necrotic plug)
• Effectiveness - (lesion-free _at_ gt1 year)
• Long term sequelae - problems after 1 month
  (stenosis, infertility, obstetrical problems)

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Acceptability - Best Evidence(43 papers)

• Vasomotor - 10 to 20 (Townsend 71, 83)
• Pain - lt labor, 4 (scale of 0 to 10) (Sammarco
  93, Harper 97)
• Discharge - universal, 1/3 malodorous, usually
  lt 1 month (Berget 87)
• Spotting - lt 1/4, 3 days (Kwikkel, 85 Berget
  87)

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Safety/ComplicationsBest Evidence (40 papers)

• PID - lt 1 (Mitchell, 98 Berget, 87), higher
  in adolescents (10)
• Severe Bleeding - none reported (Mitchell, 98
  Kwikkel, 85 Townsend, 83 Berget, 87)
• Necrotic plug syndrome - lt3 (Schantz, 84
  Berget, 87 Creasman, 73) suspect this is due
  to endocervical canal freezing-not recommended

lt1 month
40
Sequelae Best Evidence (32 papers)

• Stenosis - lt 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

gt 1 month after treatment
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Effectiveness - Cure Rates

• Colposcopy cytology _at_ 1 year
• histologic confirmation
• Double Freeze CIN 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

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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)

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Overview Conclusions

• Cryotherapy 90 effective for ectocervical CIN
  lesions
• Acceptability
• vasomotor, spotting lt25
• pain, discharge - universal
• Safety - PID lt 1, Necrotic plug lt 3
• Long term sequelae - poor evidence

44
LEEP/LLETZ

• LEEPLoop Electrosurgical Excision Procedure
• sometimes referred to as LLETZ Large Loop
  Excision of the Transformation Zone

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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.

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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.

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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
LEEPAdverse 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.

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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.

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Cone Biopsy
51
Cone Biopsy
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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.

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Cone BiopsyPossible Serious Side Effects

• Bleeding
• Infection

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Cone BiopsyPossible 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.

55
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.

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Danforths Obstetrics Gynecology, 6th edition
Hysterectomy
57
HysterectomyPossible Side Effects

• Bleeding, infection, accidental injury to other
  organs, such as the bowel or bladder.
• Ovaries may also be removed, creating a
  menopausal state.

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Goal of a Cervical Cancer Prevention Program

• To reduce the incidence, morbidity and mortality
  from cervical cancer.

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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
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Model of an Information Reporting System

• Cytology Labs
• Identifiers
• Personal data
• Smear data

• Health Centers
• Cytology Labs
• Histopath. Labs
• Screening Treatment Program
• Government
• Researchers

Cervical Screening Database

• Histopathology Labs
• Identifiers
• Biopsy/treatment data

Editing Linkage
Periodic Linkages with Ext Databases

• Colposcopy/Treatment Center
• Identifiers
• Colpo Diagnosis
• Treatment

Population Database
Mortality File

• Hospital
• Data
• hysterectomies

Cancer Registry
adapted from Marett L. Cancer Care Ontario, 2001
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Core Indicators for Program Evaluation

• Coverage ( of population of interest screened)
• Follow up of positive tests
• Inadequate rate of cytology
• Histopathology-cytology agreement
• Performance testing

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Core Indicator - Coverage

• Screening data from all cytology labs which are
  linked to give woman-specific information.
• Population register.

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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.

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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.

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Data for Continuous Program Monitoring

• Data quality is preferable to quantity
• Only collect essential data that will be used.

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Indicators and Corrective Actions
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Sources of Clinical Care Data

• Screening, Referral, Recall
• Cytology lab records
• Screening clinic records
• Colposcopy, Diagnosis, Treatment, Recall
• Colposcopy clinic records
• Histopathology lab records

68
Communication of Results and Recall

• Effective information and outreach systems ensure
  that patients receive test results, periodic
  screening and appropriate follow-up after
  treatment.
• Women who have negative screening results should
  come for periodic repeat screening.

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Record of Screening

• Screening provider should keep a register of each
  smear sent to lab, test result, communication
  with client.
• Medicolegal implications.

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Record of Referral Visit

• Colposcopist should keep a register of each
  client seen final diagnosis communication with
  client.
• Medicolegal implications.

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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.

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John Sellors, MD, MScSenior Medical
AdvisorReproductive Healthjsellors_at_path.org206.
285.3500

• www.path.org