12086.pdf
Media
- extracted text
-
w-'
i
Cervical Dysplasia Treatment in
Developing Countries:
A Situation Analysis
i
Ifc
■
St >
I
te
m-' ■
Amie Bishop, M.S.W., M.RH.
Jacqueline Sherris, Ph.D.
Vivien Davis Tsu, Ph.D.
July 1995
•;
■
■
O'
E
IK
path
Program for Appropriate Technology in Health
4 Nickerson Street
Seattle, Washington 98109-1699 USA
Donated by Dr. C M Francis in Feb. 2010
Cervical Dysplasia Treatment in Developing Countries:
A Situation Analysis
by
Arnie Bishop, M.S.W., M.P.H.
Jacqueline Sherris, Ph.D.
Vivien Davis Tsu, Ph.D.
July 1995
path
Program for Appropriate Technology in Health
4 Nickerson Street
Seattle, Washington 98109-1699 USA
Tel: (206) 285-3500
Fax: (206) 285-6619
Internet: info@path.org
WWW: http://www.path.org
This document was prepared for the World Bank Population, Health, and Nutrition
Department’s FY94 program to support Safe Motherhood.
ACKNOWLEDGMENTS
We would like to thank the Population, Health, and Nutrition Department of the World Bank
for supporting the research and preparation of this document. In particular, we would like to
thank Ms. Kirrin Gill and Ms. Anne Tinker for their helpful feedback and encouragement.
Thanks are due as well to our many colleagues at PATH who provided input on content and
presentation of the document. We also would like to express our special thanks to the
following expert reviewers, whose input was greatly appreciated: Beverly Barnett, MB, MS,
DM, MPH (PAHO, Bridgetown, Barbados); Peter Blake, MD, FRCR (The Royal Marsden
NHS Trust, London, England); Paul Blumenthal, MD, MPH (JHPIEGO, Baltimore, USA);
Z.M. Chirenje, MRCOG (University of Zimbabwe, Harare, Zimbabwe); Beatrice GuyardBoileau, MD (Ob/Gyn consultant, Seattle, USA); Khama O. Rogo, MD, PhD (University of
Nairobi, Nairobi, Kenya); Ralph Richart, MD (Columbia University, New York, USA);
Robert Scott, MD (Swedish Medical Center, Seattle, USA); Jan Stjemsward, MD, PhD and
Saloney Nazeer, MD (WHO, Geneva, Switzerland); and Franklin White, MD (PAHO,
Washington, D.C., USA). The assistance of these reviewers was invaluable in ensuring that
the document was accurate and appropriate. Any errors in the text remain the responsibility
of the authors. Finally, we would like to thank NanCee Sautbine for her production
assistance.
Amie Bishop
Jacqueline Sherris
Vivien Tsu
July 1995
I
I
I
I
I
•
Treatment of preinvasive cervical disease is more cost-effective than treatment of
invasive disease.
•
Integrated services are more cost-effective than vertical ones and are more likely to
achieve broad population coverage.
•
General physicians and non-physician providers should be trained to perform simple
outpatient CIN treatment (and screening). Non-clinicians also could be trained to do
history-taking and counseling of women being treated for CIN.
•
More limited, outpatient treatment methods (like cryotherapy and LEEP) are highly
effective, less expensive, safer, and more acceptable than inpatient methods such as cold
knife conization and hysterectomy.
•
First priority should be given to treating all women with high-grade lesions.
•
Women, health care providers, key community leaders, and policymakers must
understand and support the cervical cancer control program for it to be effective.
With these principles in mind, a planning group should be established to develop a plan of
action with the input of key decision-makers, clinicians, and women and women’s health
advocates.
Conclusion
The survey undertaken for this report suggests that existing outpatient modalities such as
cryotherapy and LEEP are not sufficiently available in many developing country settings, and
clinicians still must rely primarily on cone biopsies and hysterectomies to treat CIN. Since
these inpatient methods are much more costly and require more infrastructure than outpatient
techniques, many women do not have access to them. In addition, reliance on these methods
makes inefficient use of scarce resources. Survey results also suggest that existing practices
involving treatment of all CIN must be reevaluated to ensure that the most rational,
appropriate, and cost-effective CIN treatment protocols are being used.
Certainly, in some countries, the resources simply do not exist to initiate a comprehensive
cervical cancer screening and treatment program. Although requiring further study,
alternative strategies such as use of an inexpensive magnification device to facilitate
treatment (and screening), however, may enhance the feasibility and cost-effectiveness of
expanding detection and treatment of preinvasive conditions. Furthermore, the strategy of
screening only higher-risk women (35 to 50 years old) and treating only high-grade lesions
may reduce the burden on health care facilities, while still achieving significant public health
benefit.
I
I
I
I
iv
I
INTRODUCTION
Cervical cancer is a leading cause of death from cancer among women in developing
countries. About 437,000 new cases of cervical cancer occur worldwide per year, nearly 80
percent of which are in developing countries (Parkin et al, 1993). In several East African
countries, cervical cancer accounts for up to 80 percent of all gynecologic cancer admissions
(Machoki and Rogo, 1990). As populations from developing countries age during the
coming decades, the number of cervical cancer cases is likely to increase significantly.
Unlike many other cancers, cervical cancer can be prevented through screening at-risk
women and treating preinvasive disease. Cervical cancer generally develops slowly (over a
period of up to 10 years) and has readily detectable and treatable precursor conditions known
as cervical intraepithelial neoplasia (CIN), or as squamous intraepithelial lesions (SIL) under
the new Bethesda system terminology. These precursor conditions have been classified
according to severity. Most low-grade SIL, which comprises CIN I and cellular atypia
related to human papillomavirus (HPV) infection, is known to regress spontaneously (or
does not progress) and generally does not require treatment, while high-grade SIL (CIN II
and particularly CIN IJI/carcinoma in situ) is more likely to progress to invasive cancer and
generally requires intervention.
Many countries in the developing world face obstacles in implementing successful cervical
cancer control programs due to a variety of financial, technical, and logistical constraints. In
Brazil in the early 1980s, for instance, screening and treatment programs for preinvasive
conditions were able to cover only two percent of women at risk (WHO, 1986). In addition,
in many countries, women often do not seek medical services until the advanced stages of
disease, when chances of successful treatment are slim and treatment is expensive. Efforts
are being made in various countries to strengthen cytology services and to identify simple,
low-cost alternative screening strategies that may improve early CIN detection. For
example, visual inspection currently is being evaluated as a screening approach in some
settings. Any real gains in reducing the incidence and mortality of cervical cancer, however,
will come not only through detecting but also effectively treating women with preinvasive
disease. (For more information on cervical cancer screening strategies in developing
countries, see Appendix A.)
In industrialized countries over the last decade, CIN management has shifted toward more
conservative, outpatient approaches. This is due to several factors, including the introduction
of colposcopy, increased knowledge about the natural history of cervical dysplasia, and
availability of outpatient technologies such as cryotherapy, loop electrosurgical excisional
procedure (LEEP), and laser surgery (Chamberlain, 1986; Giles and Gafar, 1991; Wright,
Richart et al, 1992). In many developing countries where diagnosis and treatment are being
performed, however, clinicians still must rely primarily on invasive, inpatient methods to
treat CIN such as cone biopsy and hysterectomy, resulting in over-treatment of many women.
Although appropriate for certain circumstances, these approaches are associated with signifi
cant complications and side effects and, therefore, put women who could be treated with less
invasive methods unnecessarily at risk of morbidity and mortality. In addition, conization
and hysterectomy are very costly procedures, requiring significant infrastructural support.
1
They are usually provided through tertiary or university hospitals in urban settings, which
are beyond the reach of many women who need them. Effective cervical cancer programs,
then, must reach more at-risk women with simple screening methods that are coupled with
low-cost, easy-to-use, and effective diagnostic and treatment methods, as well as appropriate
follow-up protocols.
Clearly, treatment of preinvasive cervical cancer is essential to any cervical cancer control
strategy. Identifying and introducing low-cost, outpatient CIN treatment methods, therefore,
could make a major positive impact on service delivery, both financially and from a public
health perspective.
As part of an effort to establish rational, cost-effective, and appropriate treatment strategies
for settings with limited resources, this document addresses the following questions:
What grades of CIN (or SIL) should be treated?
Which treatment techniques are most appropriate for the conditions being treated?
How are preinvasive lesions and/or cervical cancer currently being managed in lowresource settings, and how could new approaches be integrated into existing services?
How do current policies affect cervical cancer screening and treatment programs?
Which CIN management strategies are most cost-effective? How is cost-effectiveness
determined for CIN treatment?
What key steps can be taken to expand access to treatment services in low-resource
settings?
Answers to these questions were derived from literature reviews, interviews with key
international cervical cancer experts and clinicians, and survey responses from over 100
developing country providers with experience in cervical cancer detection and treatment (see
box below).
A Survey of Current CIN Treatment Practices in Developing Countries
As part of an overall effort to expand access to CIN screening and treatment in developing
countries, PATH sent questionnaires to 238 clinicians and women’s health experts throughout the
world who may have had some experience in cervical cancer/dysplasia detection and treatment.
Selected recipients further disseminated the survey to their local contacts, thereby increasing
overall distribution. The survey data also were supplemented by guided interviews conducted in
several countries. No attempt was made to send the survey to a respresentative sample of
practitioners by region or by facility. Therefore, survey results provide a picture of prevailing CIN
treatment practices only in the facilities represented by respondents.
The purpose of the survey was to gather information on current CIN treatment practices in
developing countries as a basis for identifying low-cost, simple treatment alternatives that may be
appropriate for low-resource settings and could be used with simplified screening strategies.
Information also was gathered on current screening practices, costs of screening and treatment
interventions, perceived barriers to screening and follow-up care, personnel requirements, and
other logistics concerns. One hundred-ten surveys were received from over.30 countries,
representing a 46 percent return rate.
2
CIN MANAGEMENT: CURRENT STATUS
In industrialized countries, aggressively treating all grades of CIN, as defined by cytology,
was standard practice until the 1960s. For many years, hysterectomy, and even radiotherapy,
were considered necessary to treat CIN; later, large cone biopsies, which remove a coneshaped section of the cervix including the entire transformation zone, replaced hysterectomy
as part of standard CIN management (Chamberlain, 1986). Hysterectomy still is indicated
for some conditions, such as adenocarcinoma in situ, as well as for selected cases of
microinvasion and for all invasive cases. It also may be selected for women who have
completed childbearing and who may be unlikely to return for follow-up. In general,
however, hysterectomy is unnecessarily radical for the treatment of CIN and carcinoma in
situ (CIS) and is clearly unacceptable for women who wish to retain their fertility.
Similarly, although cone biopsy is relatively effective in both diagnosing and eradicating
high-grade SIL (CIN II and III/CIS), it is no longer generally indicated as an initial
diagnostic procedure because of significant morbidity such as immediate and prolonged
bleeding, cervical stenosis, and increased incidence of spontaneous miscarriage and
obstructed labor in subsequent pregnancies. In women with a suspicion of invasive disease,
cervical gland involvement, or an unsatisfactory colposcopy, however, cone biopsies still
may be recommended. Cone biopsy also may be indicated if colposcopy is not available and
invasive cancer cannot be ruled out by random biopsies or other means (WHO, 1986).
The introduction of colposcopy played an important role in the shift from radical treatment
to more conservative approaches by enhancing the ability of clinicians to visualize abnormal
cytology and to pinpoint the location, extent, and degree of diseased cervical tissue (Giles
and Gafar, 1991). Colposcopy (which uses a special scope to magnify the cervix) primarily
is used to further evaluate cervical abnormalities, guide diagnostic punch biopsies, and
facilitate local treatment of histologically confirmed lesions. Endocervical curettage also is
sometimes used to facilitate diagnosis of endocervical lesions, particularly in the United
States (U.S.). The procedure involves scraping the cervical canal to collect endocervical
cells that are then examined to ensure that invasive cancer has not been missed by biopsies or
colposcopy. It is not practiced widely outside of the U.S. as it adds time, expense, and
requires the use of a special curette. In addition, its added value to the diagnostic process
may not always be significant, particularly if the lesion or transformation zone is completely
visible.
Current diagnostic and treatment protocols in industrialized countries dictate that women
with abnormal smears requiring further evaluation must return to the health care facility for
colposcopy. During this visit, the woman’s cervix is assessed visually, a cervical smear may
be repeated, and colposcopically directed punch biopsies are taken. The biopsy samples are
then sent to a pathology laboratory for analysis, and several weeks may pass before results
are available. If the CIN diagnosis is confirmed histologically, the woman is then asked to
return again for treatment. Recently, clinicians, particularly in Europe, have begun to adopt
the “See and Treat” approach to treating preinvasive lesions, whereby excision of tissue for
diagnosis and treatment is performed immediately following a colposcopic evaluation. This
3
approach bypasses the diagnostic biopsy stage and may have important implications for
developing countries since it reduces the number of visits a woman must make to receive
proper care (see page 20).
An increased understanding of the etiology and natural history of cervical cancer over the
years also has changed CIN management. Although it was once believed that preinvasive
lesions progressed through mild, moderate, and severe stages before developing into cancer
(as reflected in the traditional Pap smear classification system using CIN I, II, and HI),
research now indicates that most mild dysplasia, classified as low-grade SIL, will
spontaneously revert to normal without therapy (Nasiell et al, 1986). Further, preinvasive
cervical lesions appear to be caused by the human papillomavirus, a sexually transmitted
disease (STD) (Schiffman et al, 1993). A variety of HPV types exist and are classified
according to oncogenic risk and DNA base pair sequence. Low-grade SIL is associated with
both high- and low-risk HPV types, whereas high-grade lesions are associated only with
certain high-risk HPV types (e.g., HPV 16 and 18). High-grade SIL (CIN II and CIN III/
CIS) is considered a clear precursor to invasive cancer; up to 70 percent of untreated CIS
lesions, in particular, progress to invasive cancer within ten years (Richart, 1995) (see
diagram on CIN natural history, page 5).
This view of cervical cancer’s natural history has important implications for establishing
appropriate CIN treatment strategies. For example, since the majority of low-grade lesions
are likely to regress, these lesions could be monitored (if possible), while reserving local
destructive or excisional therapy for high-grade lesions only. (For more details on cervical
cancer natural history, see Cervical Cancer in Developing Countries: A Situation Analysis,
Sherris et al. World Bank, 1993.)
DEVELOPING TREATMENT STRATEGIES: WHICH CIN GRADES SHOULD BE
TREATED?
The main goal of any cervical cancer screening program is to identify women at high risk for
developing cervical cancer and to treat those who clearly require intervention. Efforts to
reach as many high-risk women as possible should not result in compromised quality of care,
however.
As knowledge has increased regarding the natural history of CIN and the role of HPV, the
standard treatment strategy used in most industrialized countries suggests that only CIN II
and III should be treated. Of course, individual country strategies will depend on
assessments of local capability to treat or monitor women, local epidemiology, and cost
factors, among others.
For example, additional factors may need to be considered in determining the need for CIN
treatment among women infected with the Human Immunodeficiency Virus (HIV), since
some evidence suggests that the coexistence of HIV may alter the natural history of CIN.
Some studies indicate that HIV-positive women may have higher prevalence rates of HPV
and CIN, higher CIN grades, and higher recurrence rates than uninfected women after
4
Natural History of Cervical Cancer:
Current Understanding
Normal Cervix
4
About 60% regress
within 2-3 years*
HPV Infection
HPV-related Changes
4
ir,
Low-Grade SIL (Atypia, CIN I)
4
About 15% progress within 3-4 years
Cofactors
High-Risk HPV
(Types 16, 18, etc.)
High-Grade SIL (CIN II, lll/CIS)
4
30% - 70% progress within 10 years
Invasive Cancer
*NOTE: Prevalent cases will have a lower regression rate than incident cases, on which this estimate is based.
PATH/1995
ABVR1352.PRS
standard therapies (Warren and Duerr, 1993; Maiman et al, 1993; Spinillo et al, 1994). In
addition, HIV-positive women may have more frequent involvement of the vagina, vulva,
and other portions of the anogenital area than uninfected women (Fruchter et al, 1994).
Failure to identify high-grade lesions early, therefore, could have serious consequences,
which suggests that HIV-positive women with CIN should be treated promptly and
monitored closely, if possible.
Several specific treatment approaches are described below.
Standard Approach
Treat women with high-grade lesions (CIN II, CIN III/CIS)
Limiting treatment to women with high-grade lesions is considered standard in many
countries where adequate services are available. It is reflected in the Bethesda system of
terminology, which classifies CIN II and CIN III/CIS as high-grade SIL.
Rationale and advantages: Increasing evidence suggests that a significant proportion of
low-grade SIL does not progress or regresses spontaneously (about 60 percent regresses after
an average of 39 months of follow-up), with only about 15 percent progressing to high-grade
lesions after an average of 48 months of follow-up (Nasiell et al, 1986). In addition,
progression from low-grade conditions to cancer is sufficiently slow that the risk of
developing cancer in a brief period is slight; therefore, low-grade conditions can be
monitored at appropriate intervals to ensure the lesion regresses without increasing a
woman’s risk of cancer. American College of Obstetrics and Gynecology (ACOG)
recommendations suggest monitoring women with low-grade conditions every four to six
months (ACOG, 1993); however, this is quite costly and evidence suggests that annual
follow-up screening of women with mild lesions may be sufficient. Treating only high-grade
lesions can reduce costs and lessen the stress on health care systems that otherwise might be
overwhelmed by women with low-grade cervical abnormalities.
Disadvantages: This approach requires an ability to monitor women with low-grade
conditions, which may be beyond the capabilities of some facilities. Monitoring also may be
difficult where women are rarely in contact with the health care system. In addition, since
some low-grade lesions do progress, these women may be lost to follow-up. Also, untreated
women with low-grade SIL are more likely to transmit HPV infection to sexual partners than
those who are treated (Richart and Wright, 1993). Finally, in largely unscreened populations,
low-grade lesions are likely to have existed for several years prior to detection (prevalent
cases). These lesions, therefore, may regress at much lower rates than newly developed lowgrade lesions among well-screened populations (incident cases) (Richart, 1995).
Alternative Treatment Approaches
The following approaches are more controversial but may be practical and appropriate in
some settings as first steps towards expanding CIN treatment services.
6
Treat women with severe lesions (CIN III/CIS) only
A variation of the standard approach, this strategy relies on the CIN classification system,
which distinguishes between CIN II and CIN DI, and proposes that CIN D could be
monitored instead of treated.
Rationale and advantages: In regions with very scarce resources, programs may opt to refer
and treat only women with severe dysplasia to lessen the health care burden but still achieve
significant public health impact. Evidence suggests that CIN II can regress, although at a
significantly lower rate than CIN I (Richart and Wright, 1993). The appropriateness and cost
effectiveness of this approach, therefore, will depend in part on the proportion of cases in
which CIN D, in fact, regresses among the population being screened and treated, and the
proportion of women left untreated who return for follow-up screening before invasive
disease develops.
Disadvantages: Again, this strategy requires an ability to monitor women identified with
CIN I and n, which could be difficult and expensive in some settings. In addition, it assumes
that CIN grades can be accurately differentiated cytologically. Like the previous strategy, it
also carries the risk that women whose conditions do progress (which may be more likely in
previously unscreened than regularly screened populations) may be lost to follow-up.
Finally, a decision to monitor rather than treat preinvasive disease may cause considerable
anxiety to the woman, reducing the acceptability of this approach.
Treat women with low-grade as well as high-grade lesions
Rationale and advantages: Where cervical cancer rates are high, but where monitoring and
follow-up of women is difficult or unlikely, this approach could be appropriate, particularly
since no practical and affordable method yet exists to predict with certainty which CIN
lesions will progress to cancer and which will not. Proponents of this approach also argue
that outpatient treatment is now simple, fast, effective, inexpensive, and has very few
complications (Richart and Wright, 1993). In particular, the introduction of LEEP, an
outpatient excisional method to treat CIN, has made outpatient treatment even more efficient
since LEEP permits simultaneous diagnostic tissue sampling and treatment (see page 20).
Disadvantages: The principal drawback to this approach is that it could lead to unnecessary
treatment or overtreatment, possibly resulting in side effects or complications associated with
treatment that could have been avoided. The benefits of treating all lesions, therefore, need
to be weighed against the risks of unnecessary treatment for some women. This approach
also may place a heavy burden on the health care system as well as on providers, and
potential costs to the system could be high. Women also may find this approach
unacceptable if they feel that treatment may be unnecessary.
Prophylactic ablation of the transformation zone: a controversial approach
A fourth, more controversial strategy suggests that prophylactic ablation of the
transformation zone, most likely using cryotherapy, be performed on all at-risk women in a
7
given area, even when they have no evidence of CIN. The theory behind this approach has
been likened to that of immunization, whereby all individuals (for example, children under
five years old) are immunized against particular diseases regardless of whether they are truly
at risk.
Early studies in the U.S. indicated that ablating the transformation zone provides long-term
protection against or at least delays subsequent development of cervical neoplasia. This
approach essentially eliminates the need to screen as frequently as is generally
recommended, and it addresses the difficulties in following-up women who are rarely in
contact with the health care system. Specific protocols would need to be developed for
special conditions such as pregnancy, STD infection, and pelvic inflammatory disease
(Bosch and Castellsague, 1994).
Because of the risk of unnecessarily exposing women to side effects and complications,
however, this approach raises serious ethical questions and likely would make recruiting
women for a study difficult. In fact, the only scenario in which this approach might be
appropriate would be in high prevalence settings where screening services have never been
available and are unlikely to become available in the near future. As with previous
strategies, the possibility of reducing cervical cancer mortality using this approach must be
weighed against the risks of possible side effects and complications from unnecessary
treatment. Acceptability of this strategy to women also would be a major concern.
OUTPATIENT TREATMENT TECHNIQUES: A TECHNICAL REVIEW
Determining which outpatient treatment techniques are most appropriate for a particular
setting is an important part of establishing a cost-effective and feasible cervical cancer
control program. Outpatient therapy is appropriate for visible lesions on the ectocervix when
invasive cancer and endocervical involvement have been ruled out. Over the past several
decades, numerous ablative and excisional methods to treat preinvasive cervical disease have
been used. Ablative methods, which destroy the abnormal tissue, include cryotherapy, cold
coagulation, laser vaporization, and electrosurgery. Excisional methods include cone biopsy
(an inpatient procedure) and, most recently, loop electrosurgical excision procedure.
Excisional methods have the advantage of providing tissue specimens for histopathologic
diagnosis (if available), which sharply reduces the possibility of overlooking invasive cancer.
(Table la reviews key outpatient treatment techniques, while, for comparison, Table lb
provides information regarding hysterectomy and cone biopsy.) Since all treatment
techniques are associated with recurrence rates of up to 10 percent, post-treatment cytologic
follow-up at approximately three-month intervals for one year and then annually thereafter is
generally recommended, although some clinicians believe that longer follow-up intervals are
acceptable (except in the case of CIS). Given the natural history of CIN, however,
determining the true effectiveness of treatment is problematic (see box on page 11). In this
document, unless otherwise noted, effectiveness refers to the ability of a particular treatment
technique to completely eliminate high-grade lesions without recurrence.
8
Table 1a: Outpatient CIN Treatment Approaches
Ablative Methods1
Cryotherapy2
Effectiveness
70-90% for CIN in
Potential side effects
Excisional Methods
Cold Coagulation
Electrocautery
Loop Electrosurgical Excision
Procedure (LEEP)
85-89% for CIN HI
90-95% for CIN III
Watery discharge for 2 weeks, Bleeding, pain, uterine
infection risk, receded transfor cramping, vaginal discharge
mation zone
Uterine cramping, pain,
bleeding, cervical stenosis,
receded transformation zone
Bleeding, infection risk
Training requirements
Low
Moderate
Moderate-high
Anesthesia requirements
None, though some women may None, though some women
prefer local anesthesia
may prefer local anesthesia
None
Local anesthesia
Supply requirements
Refrigerant-i.e., liquid nitrogen Probes, needles, syringes,
or carbon dioxide, local
local anesthesia, Lugol's
anesthesia, needles, syringes,
solution
Lugol's solution
Needles, syringes, local anesthesia,
Ball-type and return elec
trodes, needles, syringes, local loop and ball-type electrodes, return
electrodes, suture set, Lugol's solution,
anesthesia, Lugol's solution
vasoconstrictive agent, Monsel's paste
Equipment requirements
Cryotherapy unit, cryoprobes,
Electrosurgical generator
colposcope or low-power
(Semm Cold Coagulator),
magnification device, speculum, colposcope or low-power
examination table, light source magnification device,
speculum, examination table,
light source
Electrosurgical generator, non- Electrosurgical generator, colposcope
conductive speculum,
or low-power magnification device,
colposcope or low-power
non-conductive speculum, smoke
magnification device, exami evacuator
nation table, light source
Personnel requirements
Physicians, nurse-midwives, or
nurse-practitioners
Physicians, nurse-midwives,
or nurse-practitioners
Physicians, nurse-midwives,
or nurse-practitioners
Physicians
Infrastructure
requirements
Record keeping, counseling,
follow-up, reliable source of
refrigerant
Power supply, record keeping,
counseling, follow-up
Power supply, record keeping,
counseling, follow-up
Power supply, record keeping,
counseling, follow-up
Costs
Initial cost: US$l,000-$3,000;
low recurrent costs
Initial cost: US$1,000$2,000; low recurrent costs
Initial cost: US$l,000-$2,000
Initial cost: US$4,000-$6,000;
US$15-$60/loop
92% for CIN HI
Low
'Other methods, such as laser vaporization, are not described in this table because their technical requirements and high cost make them less suitable for low-resource settings.
2Cryotherapy is the only method that does not require electricity.
Table 1b: Treatment Approaches for Early and Advanced Cervical Cancer
Early Cancer
Advanced Cancer
Cone biopsy/hysterectomy
Hysterectomy plus radiation/
chemotherapy/palliative care
(depending on stage of cancer)
Effectiveness
Varies with extent of cancer
Often not successful; 5-year survival
rates less than 35%
Training requirements
High
Very high
Potential side-effects &
complications
Bleeding, cervical stenosis,
spontaneous miscarrage, obstructed
labor, infection, and other side
effects and complications of surgery
Side effects and complications of
surgery and radiation/chemotherapy
Anesthesia requirements
Local, spinal, or general anesthesia
(depending on technique used1)
General or spinal anesthesia
Supply requirements
Surgical supplies, anesthesia
Extensive
Equipment requirements
Colposcope, surgical equipment
Extensive
Personnel requirements
Gynecologists
Medical specialists (surgeons,
radiologists)
Infrastructure
requirements
Well-equipped hospital; ability to
recall women post-treatment
Well-equipped hospital; ability to
recall women post-treatment
Costs
High
Very high
’New cone biopsy techniques using CO2 lasers may be performed under local anesthesia in some cases.
Ablative Methods
Cryotherapy
Procedure: Cryotherapy destroys abnormal cells by using a low-temperature probe (-60° C
to -90° C) to freeze the transformation zone. Cryoprobes varying in size and shape may be
used depending on the size and grade of the lesion as well as on the shape of the cervix.
Carbon dioxide (CO2), liquid nitrogen, or nitrous oxide are generally used as refrigerants.
Cryotherapy can be done without anesthesia, although one study indicated that using local
anesthesia reduced discomfort significantly (Sammarco et al, 1993).
10
Measuring Treatment Effectiveness: Methodological Issues
Treatment effectiveness, usually expressed as cure rates (or failure rates) can be defined in
several ways and may be misleading when applied to CIN treatment. A major difficulty in evalu
ating CIN treatment effectiveness is separating the spontaneous regression of CIN lesions from
the impact of a treatment modality: lower grades of dysplasia often regress spontaneously,
therefore it is not surprising that “cure rates” are higher for these conditions than for high-grade
conditions. Since studies suggest that about 60 percent of CIN I regresses in screened (“inci
dence”) populations, a “cure rate” of 90 percent among women with CIN means that the treat
ment modality contributed to only 30 percent of cures. (In unscreened, “prevalence” populations,
regression rates are much lower.) Because of this fundamental difficulty, treatment studies that
report only overall cure rates (for CIN I, II, and III combined) are not as helpful in evaluating a
given treatment modality than studies that report cure rates separately for low- and high-grade
preinvasive disease. In addition, most studies are descriptive rather than randomized evalua
tions.
Another difficulty in evaluating treatment studies is that the literature often is inconsistent in how
effectiveness is expressed. Some studies distinguish between persistence rates (the proportion
of CIN that persists despite treatment) and recurrence rates (the proportion of CIN that recurs
after complete eradication of lesions). Many studies, however, combine persistence and recur
rence rates to measure effectiveness and may consider repeat treatment in their calculations.
Similarly, complications and side effects may be defined differently, depending on the study.
Another important factor in calculating effectiveness is length of follow-up. Many studies calcu
late effectiveness based on examination three months post-treatment (often referred to as the
initial cure rate). A minimum of one year (or longer, if possible), however, may be necessary to
accurately assess effectiveness.
In this document, wherever possible, studies that distinguish treatment effectiveness for high
grade disease from effectiveness for all CIN are highlighted. Also, emphasis has been placed on
studies that report longer follow-up; ideally one year or more. Readers should remain aware,
however, of the limitations of reported “cure rates” for various treatment methods.
Effectiveness: Overall cure rates for this method range from 84 to 96 percent for all grades
of CIN (see Table 2, page 12). Several studies indicate that effectiveness increases
significantly using a “double-freeze” (instead of “single-freeze”) technique (Schantz and
Thormann, 1984; Bryson et al, 1985). For this technique, the cervix is frozen for three
minutes, thawed for five minutes, and refrozen for another three minutes. A ball of ice fourto five-millimeters in diameter must form past the edge of the lesion with each freezing to
ensure adequate tissue destruction. (Large lesions may require multiple applications to
ensure that this occurs.) In one study, the recurrence rate after one year for all grades
following double-freeze treatment was 8.8 percent, compared to 6.3 percent using the single
freeze method. Failure rates were highest among women with severe lesions treated with the
single-freeze technique (Schantz and Thormann, 1984).
Effectiveness also is affected by the severity and size of the lesion treated (Creasman et al,
1981; Creasman et al, 1984). Reported cure rates range from about 70 to 90 percent in
women with CIN III. Most researchers suggest that cryotherapy is appropriate for CIN III
provided that patients are able to adhere to rigorous follow-up.
11
Other studies suggest that the apparent association between lesion grade and treatment
success rate may be due, in fact, to the association between lesion size and grade (Townsend,
1979; Richart et al, 1980; Bryson et al, 1985). One study showed that when controlling for
lesion size, the grade of dysplasia did not influence the cure rate. Lesion size, however, was
significantly associated with cure rate regardless of grade (Arof et al, 1984). Another study
indicated that treatment failure was significantly associated with large, high-grade cervical
lesions, particularly those containing high-risk HPV types (Guijon et al, 1993).
One descriptive study suggested that cryotherapy may be more effective in women under 30
years old. Researchers found that the cure rate for this group for all grades was 88 percent
after five years, compared to 77 percent for women over 30. This may be because older
women are more likely to have high-grade, aggressive disease. Also, women over 30 are
more likely to have lesions that extend into the cervical channel where it is difficult to
achieve adequate freezing (Hemmingson et al, 1981).
Table 2
Cryotherapy for Treatment of CIN:
Key Studies with at Least 1 Year of Follow-up
Author
Year
Overall
Number of
Cure Rate
Women
(Percent)
CIN III
Cure Rate
(Percent)
Follow-up
Andersen & Husthe
1992
261
83.5
77.8
7 years (mean)
Olatunbosun et al.
1992
70
90
80.8
5 years
Berget et al.
1991
93
96
90.5
2 years
Draeby-Kristiansen et al.
1991
96
92
86
10 years
Ferenzcy
1985
147
93.2
71
1 year
Bryson et al.
1985
422
92.9
1 year
Creasman et al.
1984
770
89.9
82.3
2 years
Townsend & Richart
1983
100
93
88
1 year
Monaghen et al.
1982
159
87.4
85
1 year
Wright
1981
152
85.5
75
12-42 months
Benedet et al.
1981
906
88.2
87.2
1 year
Hemmingson et al.
1981
181
84
82
5-8 years
12
Side effects: After treatment, the cervix takes about six weeks to heal. The most prominent
side effect is profuse, watery discharge for two to four weeks post-treatment. Cryotherapy
does not appear to impair subsequent fertility or childbirth, however, and has been performed
safely during pregnancy (Benrubi et al, 1984). Another potential problem with cryotherapy
is that the transformation zone tends to recede into the endocervix post-treatment,
particularly if an inappropriately sized probe is used or if the woman is post-menopausal.
Given the high cure rate of cryotherapy, particularly for mild and moderate lesions, however,
the inability to visualize the transformation zone in women who may be screened only once
or twice in their lives may be offset by the benefit of providing effective treatment.
Equipment and supply requirements and costs: Cryotherapy units generally vary in initial
purchase price from about US$1,000 to $3,000 in developing countries. The thermos-like
canisters containing refrigerant can be filled and reused and are available in a wide variety of
sizes. For example, CO2 canisters range from 2 kg canisters, which enable treatment of
approximately four to five people, to 130 kg canisters or larger. Although each type of
refrigerant has different freezing points, all are effective in treating CIN. Liquid nitrogen
and nitrous oxide are cleaner than CO2, leading to fewer mechanical problems related to
blockage of the tube from the tank to the probe (Creasman et al, 1984). They are, however,
more expensive than CO2. To avoid blockage problems, only medical grade or “bone dry”
CO2 should be used. It is important that adequate tank pressure be maintained. If tank
pressure is low, optimal temperatures may not be reached and tissue destruction can be
inadequate. Various sizes of cryotherapy probes also are available. Probes of adequate size
to completely cover a lesion must be used for successful treatment.
Cold coagulation
Procedure: Originally invented in the 1960s to treat benign cervical conditions, cold
coagulation involves the cervical application of a thermal probe heated to 100° C using the
Semm Cold Coagulator. Several 20-second applications are usually necessary to cover the
entire transformation zone. Although not required, local anesthesia may be used to reduce
discomfort. Cold coagulation has been used primarily in Europe, and several studies have
indicated that it is quite effective and is associated with minimal complications.
Effectiveness: Most studies have reported overall success rates of 92 to 97 percent (see
Table 3, page 14). One study, spanning 14 years, indicated a 92 percent success rate after
five years in treating CIN III (Gordon and Duncan, 1991). Another, spanning 13 years,
found that cold coagulation had success rates after five years of 96.5 percent for CIN I and
95.4 percent for CIN II (women with CIN HI were not included) (Loobuyck and Duncan,
1993). In both studies, women experienced few complications, and no impairment of future
fertility was noted.
Side effects: Though reportedly minimal, side effects may include some pelvic cramping
during treatment. In a small percentage of cases, bleeding, vaginal discharge, or some
residual pain may occur for several weeks post-treatment. Scarring has not been reported as
a problem.
13
Table 3
Cold Coagulation for Treatment of CIN: Key Studies
Author
Year
Number of
Women
Loobuyck & Duncan
(CIN I & II Only)
1993
1,165
Williams et al.
1993
125
Efficacy
Follow-up
CIN I - 96.5%
CIN II - 95.4%
5 years
96.5%
18 months
(cin ii & m)
Gordon & Duncan
1991
1,628
92%
(CIN HI Only)
5 years
Equipment and supply requirements and costs: The equipment necessary to perform cold
coagulation, which includes a Semm Cold Coagulator and a variety of probes, is relatively
inexpensive (about the same as cryotherapy equipment), and the unit operates on mains
electricity. One clinician in Argentina indicated that cold coagulation costs only US$0.28 per
application, thus making it an extremely cost-effective intervention in that setting (Vasquez,
1994). Indeed, given this method’s effectiveness, cost, and relative lack of serious side
effects, it may well be appropriate for low-resource settings, provided electricity is available.
(In the absence of mains electricity, the unit may be adaptable to 12-volt battery power or
110-volt generator.) The primary drawback, however, is the limited access to equipment in
most countries. Other drawbacks include very limited study and use of the method in current
programs outside of Europe. According to the survey, only about five percent of respondents
currently use this method.
Ablative electrosurgery
Procedure: Two types of ablative electrosurgery have been used to treat CIN: cauterization
(or electrocautery) and electrocoagulation diathermy. Electrocautery uses an electrically
heated probe reaching very high temperatures to destroy abnormal tissue. It has been known
since the early 1900s and was used for years to treat benign chronic cervicitis and erosion. It
also was used in the U.S. in the 1930s and 1940s, before screening methods were available,
as a prophylactic measure to prevent cervical cancer. Some early studies indicated that
women treated prophylactically had a much lower incidence of the disease than untreated
women (Wright, et al, 1992b).
Electrocoagulation diathermy is similar to electrocautery but uses ball-type electrodes to
ablate surface tissue and needle electrodes, inserted repeatedly, to destroy deeper tissues.
Initially, this method was used with general anesthesia, although a 1989 study indicated that
local anesthesia could be used instead without compromising comfort and effectiveness
(Chanen, 1989).
14
Effectiveness: Once Pap smears became available, ablative electrocautery was used as a
method to treat all grades of CIN. Studies suggested initial cure rates for CIN III of about 85
to 89 percent (Schuurmans et al, 1984; Deigan et al, 1986). Studies of radical diathermy
electrocoagulation reported cure rates up to 98 percent for all grades of CIN (Chanen, 1989).
Side effects: Ablative electrosurgery is rarely used in industrialized countries now because it
is associated with significant side effects such as cervical stenosis and recession of the
transformation zone into the endocervical canal, which makes future screening difficult.
Significant pain and uterine cramping and bleeding, particularly in women 40 or older, also
are associated with this method (Chanen, 1989; Wright, et al, 1992b).
Equipment and supply requirements and costs: Required equipment is relatively inexpensive
and includes an electrosurgical generator and ball-type and/or needle electrodes.
Electrosurgical methods also require electricity.
Local anesthesia is required for radical diathermy electrocoagulation but not for
electrocautery.
Laser vaporization
While carbon dioxide laser vaporization is an effective method that allows precise
destruction of cervical lesions under local anesthesia, it is generally inappropriate for lowresource settings because it is very expensive (up to US$80,000 for initial purchase of
equipment) and requires substantial training and practice. Some randomized, comparative
studies have indicated that laser therapy holds little advantage over cryotherapy in terms of
cost, side effects, complications, and efficacy (Townsend and Richart, 1983; Wetchler, 1984).
Carbon dioxide laser ablation provides a higher cure rate than cryotherapy on initial
treatment of CIN, although effectiveness is virtually the same if women with persistent or
recurrent lesions after initial cryotherapy are retreated with the same method (Berget et al,
1991). Laser therapy is consistently more effective than cryotherapy in treating large
lesions, however (Ferenczy, 1985; Wright, et al, 1992b). Laser ablation’s principal side
effect is bleeding.
Excisional Methods
The traditional method of surgical excision of the transformation zone to diagnose and treat
CIN has been cold knife cone biopsy (conization) under general anesthesia. While effective
in eliminating CIN, conization requires hospitalization and is associated with significant
morbidity such as bleeding, cervical stenosis, and problems during pregnancy. Other
conization methods include laser excision, which can be used to excise shallow cones on an
outpatient basis using local anesthesia (although excised tissue may be damaged during the
procedure, making specimen analysis difficult), and loop electrosurgical excision procedure.
15
Loop Electrosurgical Excision Procedure (LEEP)
LEEP, also known as large loop excision of the transformation zone (LLETZ), is a method of
outpatient excisional biopsy and treatment that is used to remove the entire transformation
zone. LEEP’s primary advantage over destructive techniques is that it removes rather than
destroys suspicious tissue, thus producing a histologic sample for pathologic review. This
allows diagnostic sampling and treatment in the same visit for selected patients (the See and
Treat approach-see box, page 20). Since the entire transformation zone is excised for
histologic analysis, the presence of invasive disease can be ruled out, which is not possible
with ablative therapies.
Procedure: LEEP is performed using a thin wire electrode charged with a low-voltage, highfrequency alternating current (600kHz). The loop electrode, which is attached to an
insulated rod, is slowly moved across the cervix so that the current jumps ahead of the wire.
A clean cut is produced with only superficial coagulation, so there is little damage to the
biopsy specimen. The raw area of the cervix is further coagulated with a ball-type electrode
(Editorial, The Lancet, 1991) (see diagram below). The procedure requires local anesthesia
and generally takes less than five minutes. Loops are available in a variety of sizes,
depending on lesion and transformation zone size. Some researchers have expressed concern
that LEEP removes too much tissue; thus, clinicians are now using shallower loops (0.7 cm
deep) than those originally recommended (Richart and Wright, 1993). Loop width also may
vary. One study indicated women treated with small, narrow loops, which remove the tissue
in strips, had a lower cure rate for all CIN (about 80 percent after a mean of 12.4 months)
than those treated with wider loop electrodes (90 percent after a mean of 12.4 months),
which remove tissue in one or two passes. The wider loops also may be easier to use and
may produce a better specimen than the smaller loops (Wright, et al, 1992a). Thermal
damage to the excised tissue is generally minimal, although some damage to the edges of the
specimen has been reported (Montz et al, 1993).
3
Os
Os
w'
o
U00
E
o
£
To perform LEEP, a loop electrode is slowly moved across the cervix (a), producing
a specimen for histologic analysis (b). The cervix is further coagulated using a ball
type electrode (c).
Studies indicate that LEEP may improve the accuracy of histologic diagnosis of CIN over
colposcopically directed biopsy (Prendiville et al, 1989; Howe and Vincenti, 1991; Rattray et
al, 1993). For example, in one study comparing histologic results of colposcopically
directed biopsies and LEEP sampling from the same patients, CIN was underestimated based
on biopsy results in 16 percent of cases and overestimated in 41 percent of cases (Chappatte
et al, 1991).
16
LEEP also has been used to perform conization on an outpatient basis. Although loop
conization has a somewhat higher complication rate than simple excision, it has far fewer
complications and a faster recovery time compared with cold knife cone biopsy. Loop
conization may be indicated when CIN lesions extend a limited distance into the
endocervical canal (Mor-Yosef et al, 1990; Mayeaux and Harper, 1993; Saidi et al, 1993).
Effectiveness: Efficacy and patient acceptance of LEEP generally compare favorably to
other methods (Gunasekera et al, 1990). Average cure rates for all CIN usually range from
90 to 98 percent after three to twelve months; cure rates for CIN III/CIS also are high during
the same time frame. Lesion size rather than grade appears to influence results (Wright, et
al, 1992a) (see Table 4, page 18).
Side effects: The primary complication is perioperative and postoperative bleeding, which
has occurred in up to nine percent of cases (Prendiville et al, 1989; Gunasekera et al, 1990;
Bigrigg et al, 1990; Keijser et al, 1992; Wright, et al, 1992b). Use of Monsel’s paste may
reduce bleeding to one or two percent, however. Perioperative bleeding may be much more
significant in patients with acute cervicitis. Infection also has been reported in up to two
Patient Selection is Key to CIN Treatment Success
Regardless of which outpatient treatment technique is used, appropriate selection of patients is
key to treatment success as well as to reducing the incidence of side effects. For all outpatient
techniques (cryotherapy, cold coagulation, electrocautery, and LEEP), the first step is to rule out
(with reasonable probability) the possibility of invasive cancer, which requires more aggressive,
hospital-based therapy. It also is important to ensure that lesions do not extend into the
endocervical canal (which may be more likely in older women in whom the transformation zone
may have receded into the endocervix). These women will require an excisional method. Pap
smear, colposcopy, and biopsy results, where available, are helpful in making these decisions.
Another important aspect of ensuring treatment success is selecting the best treatment technique
for the size and grade of cervical lesion. Available data clearly suggest that cryotherapy may not
be as successful in treating more severe and/or larger lesions as, for example, LEEP. When
treating larger, more severe lesions, it is particularly important to ensure that the entire lesion has
been either ablated or removed; LEEP, using an appropriate loop size and shape, can be effec
tive in this situation. Also, where histology services are available, it may be especially helpful to
have tissue samples from larger lesions evaluated to ensure that all abnormal tissue has been
removed. If cryotherapy is the only treatment technology available, larger lesions should be
treated with appropriately sized cryoprobes, using the “double freeze” technique (see page 11).
For some women, cervical ablation or excision is contraindicated. These include women with
acute cervicitis (which could result in an increase of false-positive identification of CIN, make
identifying the treatment area more difficult, and increase the chance of post-treatment infection
and bleeding), women who are pregnant, women who are less than six weeks postpartum, and
women with bleeding disorders. In most cases, women with cervicitis can be treated after
appropriate antimicrobial therapy, and women who are pregnant or postpartum can be treated at
a later date unless the lesion is quite advanced. All of these patient selection issues should be
addressed through development of appropriate CIN treatment protocols as well as adequate
training of providers.
17
Table 4
LEEP for Treatment of CIN:
Key Studies with at Least 6 Months of Follow-up
Author
Year
Number of
Women
Overall
Cure Rate
(Percent)
Keijser etal.
1992
395
81
Wright et al.
1992a
141
94
Gunasekera et al.
1990
98
Luesley et al.
1990
Prendiville et al.
1989
Cure Rate for Post-op
CIN III/CIS Bleeding Follow-up
(Percent)
(Percent)
8
4.8 years
(mean)
94
2
6 months
95
94.7
0
6 months
557
96.6
95.7
4.3
6 months
102
97
99
4
18 months
(mean)
percent of patients, while stenosis occurs in up to one percent of patients (Prendiville
et al, 1989). Healing generally takes two to three weeks; during this time, some vaginal
discharge can be expected. LEEP appears to have no adverse effect on fertility or
subsequent pregnancy (Keijser et al, 1992; Bigrigg et al, 1994), although long-term follow
up of patients has yet to be completed.
Equipment and supply requirements and costs: LEEP requires the following equipment and
supplies:
•
electrosurgical units (produced by a number of companies at a cost of US$3,000US$6,000) that run off mains electricity and/or another power source.
•
a supply of loops, available in disposable or reusable forms (US$15 to $60 per loop,
depending on the country). Programs in countries such as India, Kenya, and South
Africa have had loops made locally (using steel wire) at a fraction of the cost of imported
loops. If reusable loops (good for 10 to 25 procedures) are preferred, they must be
decontaminated, disinfected, and cleaned thoroughly with a scrubbing pad to remove
carbonized material, and they must be sterilized before reuse.
•
compact smoke evacuator with an adequate filter to remove steam or smoke generated
during the procedure. Smoke evacuators are usually separate devices, but some LEEP
units now have them built in.
•
an insulated non-conductive or special plastic speculum (with a strong locking
mechanism) that will not allow transmission of current from the loop electrode to the
vagina and that has an outlet for smoke evacuation.
18
Other necessary supplies include a colposcope, a light source, return electrodes, a suture set,
Lugol’s solution to delineate the transformation zone prior to treatment, Monsel’s paste to
control bleeding, local anesthetic and a vasoconstrictive agent such as epinephrine, as well as
needles, syringes, and other adjunct equipment associated with administering local anesthesia
(Apgar et al, 1992).
Accessory Equipment: Magnification of the Cervix
All of the outpatient treatment methods described above typically require colposcopy to
visualize the cervix for pre-treatment assessment and, in most cases, to facilitate the
treatment procedure. Colposcopes, however, are very expensive, require substantial training
to use, and are not readily available in developing countries. Even central or provincial
referral facilities may not be equipped with colposcopes. In the Philippines, for instance,
only a few hospitals in Manila are equipped with them and few are available elsewhere in the
country.
Since some type of magnification traditionally has been
considered necessary to support CIN diagnosis and
treatment, identifying and validating an alternative to
colposcopy, such as a portable magnifying device, would
have significant implications for CIN management in lowresource settings (see diagram). For example, screening
might then be based on aided visual inspection (AVI), either
as an adjunct to or replacement for cytology, followed by
biopsy and/or treatment guided by the same device.*
Where cytology and biopsy are not feasible, a one-visit
strategy relying on visual inspection to detect and guide
One version of a low-power magnification
treatment of preinvasive lesions might be feasible
device currently being evaluated to
facilitate visual inspection of the cervix.
(see box, page 20).
In Kenya, a low-power (2.5x) magnification device was evaluated for its effectiveness
compared to colposcopy in confirming CIN and facilitating biopsy sampling. The
investigator was a trained colposcopist. Histological grading concurred with grading using
the magnifying device in 40 out of 50 women. No severe lesions were missed in any case
(Rogo, 1995). Although more extensive research must be conducted, preliminary findings
suggest that this method can yield similar results to colposcopy. In addition, given that the
alternative device is inexpensive, portable, and does not rely on electricity, it may hold real
promise in settings where colposcopes are not available. Recommendations for improving
the device include increasing the magnification from 2.5x to 4x or 6x, if possible, and
incorporating a light source (Sjamsuddin et al, 1994; Blumenthal et al, 1994).
* A number of researchers are now investigating the potential of various approaches to visual inspection to
detect preinvasive lesions. As a result, some confusion has arisen regarding terminology and definition. For
the sake of clarity, we adhere to the following definitions in this document:
Unaided visual inspection (UVI): visualization of the cervix without magnification, but with acetic acid.
Aided visual inspection (AVI): visualization of the cervix using a portable, low-power magnification device
(as opposed to a colposcope) and acetic acid.
19
Reducing the Number of Clinic Visits for Treatment: The See and Treat Approach
In many low-resource settings, especially in rural areas, women’s access to health services may be
limited due to distance from clinics, transportation costs, and family or work responsibilities. Reduc
ing the number of clinic visits for screening and treatment, therefore, may make it easier for women
to receive the care they need. One method that has been studied is the See and Treat approach,
which eliminates the need for women to wait for the results of directed biopsy before returning for
treatment. Instead, this relatively new two-visit strategy has relied on initial Pap smear screening
(visit one), followed by colposcopic examination of women with abnormal results and subsequent
treatment, if necessary (visit two). In addition to reducing the number of clinic visits, this approach
also may decrease patient discomfort and anxiety, reduce service delivery costs, and perhaps most
important, reduce the number of patients lost to follow-up who do not receive the treatment they need
(Mayeaux and Harper, 1993). Studies evaluating the feasibility of the See and Treat approach, which
have taken place largely in Europe, have found a high level of patient acceptance. In addition, it has
been shown to be extremely cost-effective as well as clinically effective (Bigrigg et al, 1990). The
See and Treat approach is not appropriate when colposcopic findings are equivocal or suggest
invasive cancer.
Most studies of the See and Treat approach have relied on LEER as the treatment of choice, since in
most developed country settings, the histologic sample provided can be analyzed post-treatment to
confirm the diagnosis and to assure that invasive cancer was not missed. The See and Treat
approach also has been used with an ablative method, however. In two studies, cold coagulation
immediately followed colposcopic assessment and directed biopsy (Gordon and Duncan, 1991;
Loobuyck and Duncan, 1993). Biopsy results were then analyzed after treatment was performed to
assure that the lesions were adequately treated.
According to some studies, approximately 5 to 39 percent of patients could be treated unnecessarily
using the See and Treat approach (Chappatte et al, 1991; Luesley et al, 1990; Bigrigg et al, 1990).
This may be beneficial to some women, however, since eliminating the transformation zone would
reduce the risk for subsequently developing cervical cancer. About 30 percent of low-grade lesions
likely contain high-risk HPV types and, therefore, are at risk of progression. Currently, however, it is
virtually impossible to determine which lesions are at risk of progressing and which are not (Wright et
al, 1992b). Thus, the morbidity and mortality from the possibility of missing more advanced disease
must be weighed against the potential morbidity of the procedure itself (Mayeaux and Harper, 1993).
In many developing countries, particularly in non-urban areas, the See and Treat technique as
practiced in developed countries (with colposcopic and histologic evaluation available) may be
impossible. Given this situation, another approach to reducing the number of clinic visits may be to
modify the See and Treat strategy so that only one visit is required. Essential to this strategy would
be the use of acetic acid and a portable, inexpensive, low-power magnification device that could be
used to detect CIN as well as facilitate outpatient treatment: women would undergo aided magnified
visual inspection to detect abnormalities and, if indicated, be treated immediately with a low-cost,
outpatient method such as cryotherapy. This one-visit strategy likely would be less accurate than
conventional approaches and may result in some women being treated unnecessarily. Further, if
cryotherapy is used, there would be some risk in ablating CIN in the absence of a biopsy specimen,
since diagnostic procedures have always been considered mandatory before proceeding to treat
ment (or as part of treatment, as illustrated by the standard See and Treat approach). Still, the
benefits in terms of treated disease and prevention of future disease may outweigh the risk of
treatment-associated morbidity in many cases, especially in high prevalence areas where screening
and treatment currently are not being provided at all. Determining the risks and benefits of these
approaches, however, must occur locally. Clearly, more research is needed to determine the effec
tiveness and acceptability of such an approach, particularly if it involves destruction rather than
excision of tissue. For either a one-visit or two-visit strategy, some system of follow-up post-treat
ment still would need to be developed; nevertheless, these strategies would greatly reduce current
cervical cancer prevention service delivery demands.
20
Guiding CIN Treatment: Future Possibilities
HPV testing for the management of CIN: Now that the causal relationship between HPV and
cervical cancer is essentially clear, using HPV diagnosis to predict cervical cancer risk is
increasingly being explored. This approach may be particularly useful in some developing
countries, where it is believed that HPV prevalence, especially among pre-menopausal
women, may be greater than in industrialized countries. Over 70 HPV types have been
identified and more than 20 are associated with lesions of the cervix and the genital tract;
these are grouped according to low, intermediate, and high oncogenic risk. Studies have
shown that the presence of high-risk HPV correlates very closely with the presence of CIN in
women referred for abnormal Pap smears, with at least 95 percent of cervical cancers and
precursor lesions containing HPV (Richart and Wright, 1993). Studies still are needed to
confirm that low-grade CIN lesions associated with high-oncogenic risk HPV types have a
higher progression rate than those associated with intermediate risk HPV and, similarly, that
lesions associated with low-risk HPV types are more likely to regress (Richart and Wright,
1993). In addition, HPV is not necessarily an independent predictor of progression or
regression of untreated CIN lesions, and other factors or co-factors apparently must be
present to cause CIN progression. Finally, high-risk HPV types also are found in about 15
percent of cervical specimens from women with normal cervices, with a mean of 25 to 30
percent of women with normal cytology being infected with some HPV type (ACOG, 1993;
Koutsky and Kiviat, 1993; Richart and Wright, 1993).
Current HPV tests, based on DNA probe technology, are largely used for research purposes
only. These assays are too expensive and complex for routine use in low-resource settings.
Currently, the most widely used HPV test is the hybrid capture assay, approved by the U.S.
Federal Drug Administration in April 1995.
I
Despite some remaining technical issues, many experts believe that within the next five to
ten years, simple, rapid HPV assays, perhaps costing less than US$4 a test, could play a role
in determining appropriate management for women with low-grade CIN or with
indeterminate results (Koutsky and Kiviat, 1993; Richart and Wright, 1993). In addition,
tests using alternative formats, such as highly accurate and easy-to-use colorimetric assays,
are likely to become available within one to two years and may eventually be affordable to
programs with limited resources.
Until research and technical issues related to HPV screening issues are better understood and
testing costs are reduced, HPV typing cannot be recommended yet as part of routine triage
for women who have suspicious results suggesting CIN. Eventually, however, it could
improve efficacy as well as cost-effectiveness of screening, colposcopic examinations, and
treatment in some developing country settings, since more rational decisions about which
women to treat and which to monitor could be made. In addition, HPV testing, possibly used
in conjunction with cytology and/or visual inspection, could be beneficial in low-resource
situations, as it has the potential to improve the efficacy of the See and Treat approach and
obviate the need for more expensive and time-consuming diagnostic procedures without
compromising quality of care.
21
Treatment of Invasive Cancer
Treatment of invasive cervical cancer (stages l-IV) relies on expensive equipment and highly
skilled medical experts to perform radiotherapy and/or hysterectomy and administer chemotherapy.
In more advanced stages of the disease, treatment options depend on the extent of tumor spread
and on patient preference (WHO, 1986). Extensive pelvic surgery and radiation are capable of
curing disease that has spread beyond the cervix, although success in the more advanced stages
is less likely (Jamison and Moseley, 1990). In fact, five-year survival rates by stage, as found in a
descriptive evaluation of 32,000 women in over 120 cancer centers in mostly developed countries,
are: 78 percent for stage I, 57 percent for stage II, 31 percent for stage III, and only 8 percent for
stage IV (Petterson, 1985). By contrast, preinvasive disease, if adequately treated, has virtually a
100 percent cure rate with simple outpatient procedures (WHO, 1986). When women seek
treatment for late-stage cancer, emphasis should shift from curative therapy to pain relief and
palliative care (WHO, 1986).
In most developing countries, treatment services for invasive cervical cancer generally are avail
able only at central teaching hospitals or large regional facilities. In some countries, women with
invasive cancer must wait up to nine months for treatment, by which time the disease may have
progressed too far for treatment success. Primary barriers include lack of affordable, maintainable
equipment and lack of trained personnel. For example, Kenya has only one cobalt radiotherapy
unit, which is located at Kenyatta National Hospital in Nairobi. The unit serves the whole country
as well as neighboring countries, which do not have cancer treatment capability (Rogo et al, 1990).
In India, ten institutions are identified as regional cancer research and treatment centers. They are
able to handle only about 10 percent of the 500,000 new cases of cancer (all cancers) that are
identified in India each year. In addition to these facilities, 77 other institutions are equipped with
radiotherapy facilities and treat patients with advanced disease (Luthra and Rengachari, 1993).
Unfortunately, at the start of any new cervical cancer screening and treatment program, a cohort of
women inevitably will be identified with invasive disease, which could strain weak health infrastruc
tures in developing countries (Elias, 1991). These women will need to be referred for appropriate
therapy or palliative care, where feasible. If women with advanced disease do not have access to
some form of treatment, the entire screening and treatment program may be viewed negatively by
women, thus discouraging them from seeking the services they need.
Given that treatment for advanced stages of cervical cancer may not be effective and is not readily
available in many countries, particularly in rural areas, health programs must maintain a focus on
early detection and low-cost management of preinvasive disease, at the same time making
appropriate palliative care available to women with incurable invasive disease.
CURRENT CIN TREATMENT PRACTICES AND PREFERENCES IN
DEVELOPING COUNTRIES: SURVEY RESULTS
Although the efficacy of low-cost outpatient treatment methods is well-established, these
technologies are not widely available in many countries for a variety of reasons. The survey
and guided interviews that were undertaken as part of this report sought to evaluate the
availability of CIN treatment interventions and to determine current CIN treatment practices
and preferences in less developed countries. In addition, the survey identified barriers to
delivering treatment services. Unfortunately, very little information was gathered on the
22
types of diagnostic procedures that are typically used to assess the need for treatment. One
hundred-ten responses were received from over 30 countries, representing a 46 percent
overall return rate. Regional return rates and a list of countries from which surveys were
received are attached as Appendix B.
The geographic and organizational distributions of the respondents are shown in Figures 1
and 2. Information on the respondent’s prior experience was not available.
FIGURE 1: Geographic Distribution of Respondents
Asia (35)
32%
Africa (41)
37%
Latin America (8)
7%
Turkey/FSU* (10)
/
9%
Caribbean (16)
15%
N=110
*FSU=Former Soviet Union
ABVP1572 PRS
Surveys were sent to clinicians and women’s health and public health specialists drawn from
professional contacts and the literature. No attempt was made to send the survey to a
representative sample of practitioners by region or by facility level. The majority of
respondents work in central or provincial facilities, with others in private, mission, or other
non-governmental facilities. Survey results, therefore, provide a picture of prevailing CIN
treatment practices primarily in those settings in developing countries and in the former
Soviet Union (FSU). The results do not provide much information on whether or not CIN
treatment is being undertaken at less centralized facilities and, if so, what methods are used,
as few respondents represented district-level or peripheral health facilities. It is likely,
however, that the majority of treatment occurs at the centralized level, thus accounting for
the high response rate from this group. A majority of responses were received from Africa
and Asia. The Middle East and Eastern Europe/Former Soviet Union regions, in particular,
were not well represented, with surveys being received only from Turkey (8), Armenia (1),
and Russia (1). This may be attributed to PATH having fewer contacts in these regions, as
well as to the lower rates of cervical cancer in some of these areas.
23
Central, provincial,
university hospitals
56%
Private, mission, or
other non-governmental
facilities
29%
District hospitals
5%
Community health center/
health post
3%
Other
0%
7%
20%
40%
60%
Percent of Respondents
N=103
80%
100%
ABVP1572.PRS
Current treatment practices: These survey results describe a sampling of CIN treatment
practices in specific developing country and FSU settings from which some possible trends
can be observed, rather than a definitive and comprehensive picture of CIN treatment
practices worldwide. Over three-quarters of respondents indicated that their facilities
currently provide treatment for CIN, while about two-thirds indicated that their facilities
treat cancer (see Figure 3). A vast majority (81 percent) also indicated that they treat women
with CIN I, as well as high-grade dysplasia. Most facilities represented in the survey also
provide some opportunistic screening.
Survey data strongly suggest that hysterectomy and cone biopsy are predominantly used to
treat preinvasive cervical disease in the countries represented, although it was unclear
whether all grades or only high-grade lesions were treated with these methods. Figure 4
indicates the types of treatment modalities for CIN that are currently being used by
respondents. No information was gathered on the frequency of use.
Several respondents from India and the Philippines indicated that cone biopsy or
hysterectomy were preferred for women with CIN who are unlikely to return for proper
follow-up as well as for older patients who have completed their childbearing. About 60
percent of respondents currently use cryotherapy, while about 41 percent currently use LEEP.
Electrocautery is being used by about 16 percent of survey respondents to treat all grades of
CIN. About seven percent of survey respondents, predominantly from Asian countries,
indicated that they are currently using laser therapy to treat CIN. Presumably, it is not used
more widely because the costs, technical maintenance, training burden, and colposcope
24
FIGURES: Grade of Dysplasia Treated
Percent of Respondents
100%
92%
80%
86%
81%
86%
67%
60%
40%
L/ -
'
20%
0%
CIN II
CIN I
CIN III
Cancer
CIS
Grade Treated
N=86
't
FIGURE 4: CIN Treatment Modalities
Currently Being Used by Respondents
100%
Percent Respondents
82%
80%
75%
60%
60%
41%
40%
20%
16%
0%
J ........
7%
1
z
z
d*
Z
J?*
I :■
5o/o
|
[
. ■■■
|
O° oo
o°9
Treatment Modality
N=86
ABVP1572PRS
25
requirements are prohibitive in many developing country settings, particularly in Africa. Just
under five percent use cold coagulation, the majority of whom were from Latin America.
By region, it appears that hysterectomy may be used widely to treat CIN in all regions except
Latin America, where respondents indicated that cone biopsy is used more widely than other
methods (see Figure 5). Respondents from Caribbean countries also indicated that cone
biopsy was used more widely than other treatment methods.
FIGURE 5: Type of CIN Treatment Now Being Used by Region
too
90
80
70
60
50
40
30
20
10
0
Percent of Respondents
L
Africa
N=31
n f
I
a
Asia
N=28
Latin America
N=7
ll rill
Caribbean
N=13
Turkey/FSU
N=8
Region
|MHysterectomy □ Cone Biopsy MLoop Excision □Cryotherapy EHOther*
’Other includes cauterization/electrocoagulation diathermy, laser, and cold coagulation.
ABVP1572.PRS
Larger differences existed among regions regarding cryotherapy and, to a lesser extent, loop
excision. Overall, a greater proportion of respondents from Asia, the Caribbean, and Latin
America appear to have access to cryotherapy and, particularly, to loop excision than those
from other regions.
If several treatment modalities were available, respondents indicated that choice of method
would depend on the following, in order of importance:
•
•
•
•
•
•
•
•
•
extent/severity of lesion
childbearing status/desires of woman/family
woman’s ability to return for follow-up visits
availability of equipment and trained personnel
existence of associated medical illness/other gynecological factors
treatment affordability to patient
availability of colposcopy
response to prior treatment
patient preference
26
I
Several respondents indicated that they currently rely on methods such as cryotherapy,
electrocoagulation diathermy, or cauterization to treat CIN I and II, and on LEEP,
hysterectomy, or cone biopsy to treat CIN m/CIS.
Survey respondents generally perceived hysterectomy and cone biopsy to be more effective
than other methods to treat severe dysplasia (CIN ni/CIS). This suggests that education of
providers will be essential if alternative, outpatient methods are to be adopted. Among the
lower-cost, outpatient procedures, loop excision is perceived to be more effective in treating
severe CIN, although cryotherapy appears to be used more widely (see Figure 6). This may
be because respondents are more familiar with cryotherapy, and therefore, its limitations,
than with loop excision. In addition, since LEEP is a relatively new treatment approach,
respondents may have assumed that it is better than the older technologies.
FIGURE 6: Perceived Effectiveness of Treatment
for Severe Dysplasia (CIN lll/CIS)
80
Percent
■ Hysterectomy
□ Cone Biopsy
■ Loop Excision
□Cryotherapy
60
i
40
■
20
I
0
Iu
Excellent
Good
ria
Moderate
Poor
Not Appropriate
ABVP1572.PRS
In some cases, experience with a particular method seems to be related to its perceived
effectiveness. For example, those respondents who have ever used loop excision tended to
rate its effectiveness as “excellent” or “good” in treating severe dysplasia (CIN III or above);
among those who had never used LEEP, a greater proportion considered it “not appropriate”
for treatment of severe CIN. By contrast, there was little difference in responses between
those with and without cryotherapy experience. Both groups tended to consider the method
only “good” or “moderate” in treating severe dysplasia, with fairly large proportions of each
group (20 percent and 14 percent, respectively) considering it “not appropriate” for treatment
of severe dysplasia.
27
CIN treatment method preference: Of the two most effective outpatient treatment procedures
(cryotherapy and loop excision), nearly 60 percent of respondents indicated that they would
prefer loop excision, while about 34 percent would prefer cryotherapy. A small number
would choose both methods, commenting that cryotherapy would be useful for CIN I and II
lesions, while loop excision or cone biopsy would be useful for CIN HI lesions and for
women with unsatisfactory colposcopic results and indeterminate smears (see Figure 7).
FIGURE 7: Outpatient CIN Treatment Method Preference
Both Methods
6%
Loop Excision
60%
I
i
Cryotherapy
34%
N=79
ABVP1572.PRS
By region, respondents from Africa indicated slightly greater preference for cryotherapy than
loop excision. This may be due to limited exposure to and knowledge about LEEP.
Respondents from all other regions preferred LEEP, with a much greater proportion of
respondents in Latin America and the Caribbean (88 and 86 percent, respectively) than in
other regions choosing this method (see Figure 8).
Perceived barriers to providing treatment for CIN/CIS: The following were listed as the
main barriers to treatment (N~97):
• Lack of a comprehensive screening program
• Cost of equipment
• Inability to follow-up women
• Lack of trained personnel
28
(66%)
(57%)
(54%)
(48%)
Inability to identify women with early,
treatable disease
• Women’s resistance to treatment
• Other*
•
(34%)
(15%)
(19%)
FIGURE 8: CIN Treatment Preference Between
Loop Excision & Cryotherapy by Region
100%
Percent of Respondents
■ Loop Excision
□ Cryotherapy
88%
II..
80%
60%
40%
20%
0%
86%
|Kfl
’/n" - ’ ’ I ’ ’ ’I”
I
nBl"inI ■ I Ira Ili
Africa
N=20
Asia
N=29
Latin America
N=8
Caribbean
N=14
o%
Turkey
FSU
N=8
Region
ABVP1572.PRS
Regionally, slight differences were noted in these results. For example, fewer respondents
from Asia than from other regions listed “cost of equipment” as a key barrier. Rather, an
“inability to follow-up women” was cited more frequently by Asian respondents. “Inability
to identify women with early, treatable disease” also was cited more often by African
respondents than by those from other regions.
1b
A detailed discussion of each barrier and of potential solutions is presented below:
Lack of a comprehensive screening program: About 66 percent of respondents identified this
as a barrier to treatment. Survey results indicated that in all regions, screening largely occurs
opportunistically, rather than as part of an integrated program, in large, central facilities as
well as in selected family planning, maternal and child health, STD, or private clinics.
*Other included: cost of travel to hospital; treatment affordability to patients; lack of patient/public
education; lack of political will; insufficient equipment, supplies, and facilities for the large number of
women needing treatment; high false-negative rate of Pap smears; crowded conditions; and long waiting time
for diagnosis.
29
Where cytology screening is already in place, respondents expressed concern about Pap
smear quality, and specifically, about high rates of false-negative results. Clearly,
establishing widespread, reliable screening is essential to reducing cervical cancer morbidity
and mortality, and simple and appropriate screening approaches for low-resource settings
that can be paired with appropriate treatment technologies must be identified. Because some
of the settings that currently provide opportunistic screening already may be providing minor
surgical care such as sterilization, they may have the capacity to provide simple, outpatient
CIN treatment as well.
Cost and availability of equipment: Nearly 60 percent of respondents indicated that cost of
equipment was a key barrier to treatment. Survey results revealed that equipment prices
varied widely among countries and presumably depended on local availability of equipment
and supplies. Still, investing in lower-cost outpatient methods to treat preinvasive conditions
is likely to lead to considerable savings in the long run, since the equipment lasts for many
years and the incidence of advanced cases should decrease, thus reducing the demand for
more expensive therapy. Finally, survival rates will be much greater, resulting in a lower
cost per Discounted Healthy Life Year (DHLY) gained.*
Obtaining supplies for some treatment technologies also is difficult. Anecdotal information
gathered in interviews suggests that there are some common problems related to cryotherapy
use in low-resource settings. For example, in Kenya, cylinders for refrigerant are in short
supply and leakage occurs frequently. This can result in improper application of cryotherapy
because of difficulty in attaining appropriately low temperatures. Improper application, of
course, likely would lead to higher rates of treatment failure and a loss of confidence in the
method.
Inability to follow-up women: Difficulty with following up women was identified as a
barrier by over half of respondents. Referral and follow-up systems are essential to
developing an effective cervical cancer screening and treatment program. Some strategies,
such as the See and Treat approach, could reduce the number of clinic visits required for
evaluation and treatment, which can take many weeks (and is also perceived as a barrier to
care). Estimates of the percentage of women who actually return for required post-treatment
follow-up varied considerably, although about 58 percent of the respondents indicated that
they had approximately 75 to 100 percent return rates (see Table 5, page 31). The mean
return rate calculated from the survey was about 71 percent. This figure may represent
highly motivated women since they were willing to be screened and to return again for
diagnosis and treatment. On the other hand, follow-up rates could be increased if specific
outreach programs were established to encourage women to return for follow-up care.
Lack of trained personnel: Nearly half of respondents indicated that lack of trained
personnel was a major barrier to providing CIN treatment. According to the survey,
gynecologists, as opposed to other clinicians, largely perform CIN treatment in all regions.
*DHLY = number of years between the age at which death would have occurred from cervical cancer and the
individual’s expected age at death, with years gained discounted at 3 percent each year.
30
Table 5:
Percentage of Women Returning
for Follow-up after Treatment
#of
Return Rate
(Percent)
Respondents
Percent of
Respondents
0-24
5
6.4
25-49
7
9
50-74
21
27
75-89
23
29.5
90-100
22
25.6
Total
78
100
Only a handful of respondents (all from Africa) indicated that midwives or nurses provide
treatment, while a few (two from Africa and one each from Latin America and the
Caribbean) indicated that general practice physicians provide it. Since many countries have
a shortage of gynecologists, reliance on these physicians to perform all CIN treatment
probably has hindered efforts to expand cervical cancer screening and CIN treatment beyond
urban areas. If mid-level practitioners, such as nurse-midwives, could be trained to perform
screening, and perhaps simple outpatient treatment such as cryotherapy, screening and
treatment coverage could be expanded in some settings. For example, nurse practitioners in
Jamaica currently are trained to provide cryotherapy. This approach may hold particular
promise in African countries, where survey results indicate that a greater variety of
clinicians, including nurse-midwives and nurse practitioners, conduct speculum examinations
as well as cervical cancer screening. The feasibility of training non-gynecologists, including
non-physicians, to perform screening and treatment, however, depends on local policies
regarding health care delivery and should be evaluated within the local context; still, this
approach warrants further exploration wherever feasible.
Women’s resistance to treatment: Only a small proportion of respondents (about 15 percent)
cited women’s resistance as an important barrier. Perceived resistance by women, however,
may be related to lack of education and information for women about cervical cancer, which
also was mentioned as a barrier by some respondents.
Other barriers: Travel costs to facilities providing treatment also was cited by respondents.
For example, many women diagnosed with CIN III/CIS in a district outside of Nairobi,
Kenya, could not afford the transportation to Nairobi for treatment. Treatment cost to
patients also is a serious barrier. Costs may vary widely among and within countries
31
depending on whether health services are subsidized by governmental or other funds. For
example, the cost of a colposcopic exam and LEEP in one Kenyan facility is over US$90,
making it impossible for most women to afford the service.
Lack of political will also was cited as a barrier in the survey. In many countries, despite
high rates, cervical cancer may not be considered a priority due to competing demands for
limited resources. Still, if cost-effective and reliable screening and treatment approaches
could be identified, some countries might be able to initiate or expand cervical cancer
prevention and control programs. Integrating these activities into existing services could
result in considerable savings in start-up costs and ultimately in costs associated with treating
advanced cancer, since the number of cancer cases would drop. To make appropriate
decisions, however, it is essential that policy makers at national, regional, and local levels be
informed of potential cost-saving strategies and persuaded of their feasibility.
Availability of Basic Supplies and Equipment
Survey findings suggest that the majority of facilities represented by the respondents are
equipped with examination tables, specula, lights, and electricity, although facilities in
African countries represented in the survey were not as well-equipped with these items as
those in other countries. Most facilities also have access to a pathology laboratory. A
majority are equipped with local anesthesia and consumable supplies, although over 30
percent of respondents from Africa (compared to between 7 and 12 percent from other
regions) indicated that their facilities experienced shortages. About 82 percent of
respondents indicated that their facilities have staff trained in administering general
anesthesia, with slightly fewer having the equipment needed to administer general
anesthesia. By region, however, over 96 percent of respondents from Asia said that they had
facilities and staff to administer general anesthesia, while fewer respondents from other
regions (57 to 75 percent) indicated that this was the case.
About three-quarters of respondents indicated that they always have access to antibiotics,
while about 22 percent sometimes have access. About 62 percent of respondents indicated
that they were equipped with a colposcope, with 38 percent indicating that they only
sometimes or never were equipped with one. Regionally, a greater proportion of respondents
from Latin America and the Caribbean (87 percent each) indicated that they always were
equipped with a colposcope, while only about 35 percent of respondents from Africa
indicated that their facilities were always equipped with one. Overall, just over half of
respondents indicated that their facilities are equipped with blood transfusion and HIV
screening capabilities, with about one-third not being equipped. A greater proportion of
respondents from Africa, Latin America, and the Caribbean than from Asia, however,
indicated that their facilities were not equipped with these services. For example, 50 percent
of respondents from Latin America said their facilities did not have blood transfusion
services, while nearly 38 percent did not screen for HIV. For Africa, the figures were 40
percent and 39 percent, respectively, and for the Caribbean, 40 percent and 33 percent.
32
With regard to supplies specifically for cryotherapy, survey results suggest that carbon
dioxide may be used more widely than other refrigerants in all developing country regions
except Latin America. Specifically, about 61 percent of survey respondents indicated that
their facilities have access to carbon dioxide (and about the same percentage now use it). It
is often procured from local sources such as soda factories or private gas companies. About
38 percent have access to liquid nitrogen and now use it. About 11 percent use nitrous oxide.
Facilities in Africa may have less access to refrigerants, in general. Of those respondents
who perform cryotherapy, over one-third (36 percent) experience delays in resupply of
refrigerants or other necessary supplies for cryotherapy.
Although facilities represented in the survey seem to have basic equipment to provide some
type of CIN treatment, respondents still indicated that for the numbers of women requiring
treatment, insufficient supplies, facilities, and equipment remained a barrier to service
delivery. In particular, respondents cited crowded clinic conditions and long waiting times
for services and laboratory results as being important deterrents to providing treatment
services.
Summary
9
Despite this survey’s limitations, data suggest that in all regions, but particularly in Africa,
low-cost, simple, outpatient procedures such as cryotherapy and loop excision may not be
sufficiently used. Rather, clinicians still rely heavily on hysterectomy and cone biopsy, even
to treat low-grade lesions. This suggests that education of providers to help change their
perception of various methods, and ultimately their methods of choice, is crucial. Heavy
reliance on inpatient methods also is likely due to limited access to alternative methods such
as cryotherapy and loop excision, as well as to lack of resources to support early detection
and treatment of preinvasive conditions. For example, “lack of comprehensive screening
programs” was listed by a majority of respondents as a key barrier to provision of treatment,
further indicating the need to identify simple and appropriate screening approaches for lowresource settings that can be paired with appropriate treatment technologies. Cost and lack
of trained personnel were other key barriers to treatment that were identified, thus
emphasizing the importance of introducing the most cost-effective and easy-to-use methods
available. In addition, inability to follow up women was cited as another important barrier;
this highlights the need to address the systems that are essential to developing an effective
cervical cancer screening and treatment program.
Regionally, it appears that countries in Asia, Latin America, and the Caribbean may have
greater access to cryotherapy and loop excision than African countries, as well as greater
capacity to incorporate these methods into their programs. This suggests that strategies for
outpatient treatment introduction likely will differ among these regions, and that introduction
efforts in Africa, in particular, will need to be carefully considered in the context of limited
resources. In all regions, however, introducing outpatient methods and clear guidelines for
their use could improve overall quality of care and extend treatment services beyond central
facilities, thereby reaching more women who need them.
33
Although little information was collected regarding CIN treatment capabilities in less
centralized facilities, it is unlikely that many peripheral centers are providing treatment,
since outpatient methods are not widespread and inpatient methods require substantial
infrastructural support. Indeed, interviews with experts in several countries suggest that
treatment is not generally provided outside main urban centers. For example, in the
Philippines, CIN treatment is generally only available at national, regional, and district
public hospitals, or at private hospitals and clinics. No treatment is done in health centers at
the local (“barangay”) level, although some peripheral facilities may conduct screening.
Similarly, in Viet Nam, treatment, which relies on cone biopsy, hysterectomy, or in some
cases, electrocautery, is available only at the provincial and central hospital levels. Further,
follow-up with women living in non-urban areas is very poor. Interviews in other countries
suggested similar conditions.
i
More information is needed on whether outpatient treatment modalities are being used or
could be introduced in less centralized facilities and, more specifically, which methods
would be most appropriate for specific settings. These methods would be valuable only if
some method of screening were in place, however. Since population-based cytology services
are very difficult, if not impossible, to implement in most low-resource settings, evaluating
alternative methods such as aided visual inspection is crucial.
Clearly, more research is needed to develop appropriate CIN treatment strategies and
interventions.
Research Needs
•
Further evaluate which treatment protocols would be most appropriate, cost-effective,
and acceptable for various low-resource settings.
•
Determine what kinds of support services such as counseling and follow-up care must
accompany CIN treatment in low-resource settings.
•
Evaluate low-power magnification as a replacement for colposcopy to facilitate
outpatient treatment (as well as screening) in certain settings.
•
Determine the level of additional infrastructural support necessary to introduce
technologies such as loop excision or cryotherapy.
•
Evaluate existing services to determine which could best absorb cervical cancer
screening and treatment services.
•
Investigate the feasibility of training other types of clinicians, such as mid-level
practitioners, to provide simple, outpatient treatment (in conjunction with screening).
•
Develop strategies to change or influence relevant policies and practices, particularly if
alternative screening and treatment methods are proven feasible and effective.
34
I
Following up Women: A Key Problem in Delivering Treatment Services
Referral and follow-up systems, after both screening and treatment, are essential to developing
effective cervical cancer control programs. In industrialized countries, it generally is recommended
that women treated for preinvasive cervical lesions receive cytological follow-up exams every three to
four months for one year, and then yearly thereafter (ACOG, 1993). (Some countries, however,
suggest longer intervals, i.e., three years between Pap smears.) In many other countries, particularly
those with large rural populations, traveling long distances to seek health services and returning for
follow-up care may be extremely difficult for many women. Further, cervical cancer screening and
treatment programs, if they exist at all, often are limited and may not have the resources to actively
recall women requiring follow-up care. For example, in India, one study indicated that only 59
percent of women participating in a large screening program were adequately followed up, and of
those, 28 percent had only one follow-up visit post-treatment (Singh et al, 1991).
Some strategies, such as the See and Treat approach, could reduce the number of clinic visits
required for evaluation and treatment, as well as eliminate the waiting time for biopsy results. This
approach, or other alternatives, may ease the burden on women and on health facilities. Other
strategies, such as mobile screening and treatment, also may improve screening coverage and
enable women to receive the treatment they need, provided that low-cost, simple treatment methods
such as cryotherapy are available. For any strategy to work, however, women, as well as their
families and health care providers, must be given information about cervical cancer through commu
nity channels so that they understand the importance of screening and treatment.
IMPACT OF CURRENT POLICIES ON CIN TREATMENT STRATEGIES
Whether formal or informal, policies regarding personnel, facilities, cost recovery, and
medical protocols have diverse impacts on the coverage, effectiveness, and acceptability of
CIN treatment services. Policies can be inscribed in codes of medical practice, in
government regulations, or more informally in customary procedure. Often, policies
established with one purpose in mind have undesirable effects on other programs that have
not been anticipated. Well-designed policies, however, can provide important guidance to
programs on how to provide good quality, cost-effective services, especially where resources
are limited. The key aspects of CIN treatment service delivery affected by policy are
detailed below:
Personnel: Based on the PATH survey results and on other reports, it appears that most
countries permit only doctors (primarily gynecologists) to carry out CIN treatment, with a
few also allowing nurse-midwives to do so. Given the heavy concentration of physicians in
urban areas, this policy clearly limits rural women’s access to this care. It also increases the
cost of such care, either to the public sector or to the private patient. Since survey
respondents cited the lack of trained personnel as one of the key barriers to providing
treatment, it is essential that the feasibility of training non-physicians be explored as a means
to expand both screening and treatment services.
Facilities: In some countries, only the central referral hospital is equipped to offer
conization, cryotherapy, or, perhaps, loop excision, although many countries also may offer
such services at large regional hospitals. Few countries make treatment, even for early
35
preinvasive cervical disease, available at the district level, largely because of financial and
technical constraints. The location of treatment services, however, is a significant
determinant of a woman’s access to care, given the difficulties and costs of transportation
and arranging coverage of family responsibilities in her absence. This was confirmed by the
survey results, which indicated that women are prevented from seeking services due to high
travel costs.
Cost Recovery: While many countries offer CIN treatment as part of public health services
(supported by the government), most require some payment by the patient, especially for
surgical or inpatient services. This trend is likely to expand as countries face growing
pressure to recover health care costs. Survey respondents noted that such fees can be a
significant barrier, however, especially for women who are asymptomatic (in the preinvasive
stage) and who may not fully appreciate the serious implications of their condition.
Effective education and communication messages directed to women at risk may help them
understand the importance of screening and early treatment so that they will seek and, if
necessary, pay for the services they need, but clearly efforts to reduce costs by adopting more
cost-effective screening and treatment technologies and protocols are essential.
Medical protocols: Medical protocols determine how patients are identified, what conditions
are treated, what treatments are used, and the steps involved in standard treatment. Which
patients are identified for treatment depends on the screening policy (active or opportunistic,
targeted at higher-risk women or younger family planning/antenatal care clients), local
epidemiology, and the effectiveness of the referral system. Many countries are conducting
only limited screening, often among younger women. Therefore, because the highest-risk
women are not screened, cases actually discovered tend to be advanced, symptomatic cases,
resulting in low demand for early treatment. The demonstrated preference for more invasive
or radical treatments noted in the survey may, in fact, partially reflect the lower proportion of
early cases detected by screening. While most countries routinely treat high-grade
dysplasias, the survey suggests that many developing countries continue to treat all lowgrade dysplasias as well, rather than adopting the more conservative “wait-and-see” approach
common in developed countries. Treating low-grade dysplasia raises the cost of care (in the
form of potentially unnecessary treatment and more women experiencing side effects) but
ensures treatment for women who are unlikely to get any further follow-up.
In terms of treatment methods, the predominant use of conization and hysterectomy reported
in the survey has serious implications for financial costs to the system and to women and
results in unnecessarily invasive procedures in many cases. The requirements for anesthesia,
equipment, inpatient care and surgical skills are much greater than would be necessary for
cryotherapy or loop excision.
Finally, the standard protocol for managing cervical abnormalities involves multiple steps, an
extended timeframe, and often multiple facilities and providers. The protocol usually
includes cytology, colposcopically-directed biopsy, histology, treatment, three-month follow
up to confirm cure, and repeated periodic follow-up visits for at least one year. The dropout
rate is high at each stage for a variety of reasons, resulting in suboptimal outcomes even
36
when abnormalities are detected. Indeed, difficulty in following up women both after
screening and after treatment was cited in the survey as a major barrier to delivering
effective cervical cancer prevention and control services. Even in developed world settings,
this multi-step protocol is not always feasible; in resource-limited settings, it often overtaxes
the system and seldom results in cost-effective care.
Programs seeking to initiate or expand CIN treatment (and screening) services are
encouraged to undertake a review of each of the issues and determine how key policies
affecting them could be changed.
IMPACT OF LOW-COST TREATMENT ON COSTS OF CERVICAL CANCER
CONTROL
Determining whether to integrate new clinical management strategies often is based on cost
factors and availability of necessary equipment and training. Based on the survey results, it
is clear that many programs still rely on expensive, invasive, inpatient procedures to treat
CIN. Capital and recurrent costs for outpatient procedures (including training), however, are
far less than for inpatient methods; furthermore, outpatient procedures should not
compromise CIN treatment efficacy.
Calculating cost-effectiveness of various treatment options must be done on a country
specific basis and requires detailed information on several different aspects of service
delivery and management. This section focuses on provider costs (public or private) in an
effort to guide decision makers on ways to incorporate financial information into cervical
cancer control program design and evaluation.
Definitions and Key Considerations
In this document, cost refers to the monetary value of inputs used. While the costs
experienced by clients are important, they are hard to quantify, and broader opportunity costs
have not been considered. Effectiveness here refers to the prevention of cases of invasive
cervical cancer (or “cervical cancer cases averted”), which is the primary goal of CIN
treatment.
Clearly, the cost-effectiveness of various CIN treatment regimens is difficult to disentangle
from costs associated with screening and with treating more advanced cases of cancer. For
example, without information on the costs associated with treating invasive cancer, it is
difficult to make a strict comparison between treating many women early and treating only
those who develop cancer later. This section focuses on early treatment only, with the
understanding that a broader range of costs (such as those associated with screening and
treatment of invasive cancer) must be included in any comprehensive country-specific
analysis (see box, page 38). For example, it would be expected that at the start of any new
cervical cancer control program, a large number of women with CIS or invasive cancer may
be identified, which initially may drive up program costs.
37
Worksheet Explanation: Defining Treatment Costs
The examples in this section and in Appendix B include estimates for cervical cancer screening
and treatment program component costs that are attributable only to the CIN treatment services
included in the program. Other factors affecting overall program costs such as screening
accuracy and coverage are considered screening rather than treatment costs and, therefore,
are held constant (and set at 100 percent) for the purposes of these exercises. Similarly, it is
assumed that the accuracy of detecting persistent or recurring CIN during follow-up evaluation
(after initial CIN treatment) also is 100 percent.
These assumptions, although unrealistic in practice, are made so that the costs for varying
treatment strategies can be directly compared. (In reality, it might be expected that 85 rather
than 100 percent of CIN is accurately detected, which would cause overall costs per CIN case
treated and costs per cervical cancer case averted to increase.) Although the worksheet
examples attempt to isolate treatment-specific costs, it is critical that in evaluating total costs
incurred by a cervical cancer prevention and control program, treatment costs are assessed in
conjunction with other major cost factors such as CIN prevalence, screening costs, and
screening accuracy.
Despite this somewhat limited focus, it is clear that the most important determinants of CIN
treatment cost-effectiveness are screening accuracy, treatment method effectiveness, and CIN
stage at treatment. Other variables, such as capital expenditures for equipment, and even
staff salaries, may vary widely with little effect on costs per cervical cancer case averted. By
contrast, slight shifts in CIN treatment efficacy, for example, have a large impact on costs per
cancer case averted. As demonstrated in the following exercise, when a treatment method
has a high degree of effectiveness, expensive follow-up treatments are avoided. Likewise, if
treatment is limited to high-grade SIL, which has a higher risk of progression to invasive
disease, the cost per cancer case averted is much lower than for strategies that treat all
grades. This is because the considerable increase in resources necessary to treat all instances
of CIN is largely spent on cases with a low risk of progression. The costs of the relatively
few additional cases averted when treating all CIN (that is, the additional costs to the
program divided by the number of additional cases of cancer prevented) can be enormous.
Calculating the Cost of CIN TYeatment
Treatment costs must include both capital costs (for equipment and training) and recurrent
costs (labor, supplies, fees for purchased supplemental services such as laboratory work,
facility use, transport, and communication). Capital costs are highly sensitive to patient load
over which the amounts can be amortized; thus, they depend on variables such as total
population, disease prevalence, and screening effectiveness. Because LEEP has multiple
surgical uses beyond CIN treatment, costs for this method could be shared over several
programs, thus reducing overall capital equipment costs. Some recurrent costs are less
sensitive to patient load. Costs of managing side effects and complications, which are a
function of the number of procedures performed and the probability and expense of treating
associated medical problems, also must be included as recurrent costs.
38
Example: Classifying costs for cryotherapy
Consider a developing country screening and treatment program that screens 250,000 women
a year, 1.5 percent (3,750) of whom have high-grade dysplasia. To calculate the principal
costs of providing cryotherapy, estimated capital and recurrent costs must be supplied for the
major components of this method. A worksheet for calculating cryotherapy costs is provided
in Appendix C, pages C-2 and C-3. Hypothetical estimates of capital and recurrent costs for
cryotherapy are listed below:
Capital Costs:
Cryotherapy units
Reusable refrigerant canisters
Staff training time
TOTAL
$8,000 (4 units @ $2,000 each)
$2,000 (8 canisters @ $250 each)
$3,000 (8 people)
$13,000
These costs include the assumed purchase of one cryotherapy unit at $2,000 and two
refrigerant canisters at $250 each for every 1,000 cases of CIN. Note that total capital costs
here do not include facilities. Note also that they do not include screening and diagnosis
capital costs, which could include colposcopes and other laboratory and clinic equipment.
Recurrent Costs:
Salaries
$24,000
Consumable supplies
$18,750
Follow-up conizations
$56,300
Treatment-related complications $ 1,900
Hysterectomies
$21,000
TOTAL
$121,950
($6,000 x 4 FTEs)
($5 x 3,750 treatments)
($100 x 563 conizations)
($50 x 38 complications)
($1,500 x 14 invasive Ca)
Salary costs are based upon the arbitrary assumption of $6,000 per full-time equivalent
(FTE) and two FTEs per 1,000 cases. Consumable supply costs include refrigerant (CO2)
needed for each cryosurgical procedure. Conization costs are based on the assumption that
about 15 percent of high-grade CIN will persist despite cryotherapy. Hysterectomy costs
cover those cases that may progress to invasive cancer despite cryotherapy and follow-up
conization.
If capital costs are amortized over five years in a straight-line depreciation, total capital and
recurrent annualized costs for cryotherapy are $124,550. This results in an estimated cost
per treatment of $33 and a cost per invasive cancer case averted of $67, assuming that 50
percent of high-grade dysplasia would progress to invasive carcinoma without treatment and
that high-grade CIN is correctly identified, both initially and during post-treatment follow
up. Therefore, 1,862 cases would be averted due to treatment. If the assumption regarding
disease progression is lowered, as would be the case where all grades of CIN are treated, the
cost per cancer case averted would be expected to rise considerably, with only a marginal
gain in the total number of cases averted. (See Appendix C, pages C-6 and C-7, for
completed worksheets on cryotherapy cost calculations based on survey data from urban
facilities in Thailand and Zimbabwe.)
39
Example: Calculating costs for LEEP
LEEP requires many of the same key capital and recurrent cost components used with
cryotherapy. LEEP equipment, however, is more expensive than cryotherapy equipment, as
are salary, consumable supply, training, and follow-up costs. Hypothetical capital and
recurrent costs are listed below:
Capital Costs:
Loop excision unit
Staff training time
Other (colposcope)
$24,000 (4 units @ $6,000 each)
$3,800 (8 people)
$80,000 (4 colposcopes @ $20,000
each)
TOTAL
Recurrent Costs:
$107,800
Salaries
$32,000
Consumable supplies
$93,750
Follow-up conizations
$18,800
Treatment-related complications $2,800
Hysterectomies
$7,500
TOTAL
$154,850
(assumes higher skill)
(assumes 5x greater costs)
(assumes fewer conizations)
($50 x 56 complications)
($1,500 x 5 invasive ca)
Based on these calculations, the costs per CIN treatment and per cancer case averted are $47
and $94, respectively. Using these estimates, an additional nine cases of invasive carcinoma
are averted by providing loop excision instead of cryotherapy at an additional annualized
cost of almost $50,000. This suggests that if these numbers were real, the cost of averting
these additional cases is $5,556 per case.
Again, using survey data from urban facilities in Thailand and Zimbabwe and estimating
some of the missing costs, a cost per loop excision treatment can be calculated (see
completed worksheets in Appendix C, pages C-6 and C-7).
INCREASING THE AVAILABILITY OF TREATMENT IN LOW-RESOURCE
SETTINGS: DEVELOPING A SITE-SPECIFIC PLAN OF ACTION
Regardless of the treatment strategy used, reaching higher-risk women, particularly in nonurban areas, will be difficult in resource-poor settings. A coordinated cervical cancer
prevention and control plan, preferably national in scope, is the best way to achieve broad
screening and treatment coverage, rational allocation and use of limited resources, a uniform
standard of care based on the best available scientific information, and an efficient planning
and monitoring process. The plan must include short-, medium-, and long-term phases that
realistically reflect local resources, priorities, and commitment levels. Education, legislation,
and national leadership are essential in developing a national plan (WHO, 1995).
General Principles and Recommendations
Each country must develop its own national plan of action for prevention of cervical cancer;
in some cases, subnational strategies may be implemented in advance of the national level.
40
While each plan must reflect local circumstances, some key principles regarding a cervical
dysplasia treatment strategy can be drawn from the available scientific literature, results of
the PATH survey, and consensus of expert opinion. These principles are as follows:
•
Treatment of preinvasive cervical disease is more cost-effective than treatment of
invasive disease.
Based on the cost information collected in the survey, as well as from other sources, it is
clear that treating invasive disease, which, depending on the stage, could include major
surgery, chemotherapy, radiation, and/or palliative care, is far more costly than treating
preinvasive disease, especially if low-cost, outpatient methods are used.
•
Integrated services are more cost-effective than vertical ones and are more likely to
achieve broad population coverage.
Existing programs such as matemal/child health, STD, family planning, or other
outpatient services may have some of the same capabilities required for cervical cancer
control already in place. These include procuring and transporting equipment and
appropriate test media; developing appropriate triage, counseling, follow-up, quality
control, and record-keeping systems; and providing staff training and continuing
education (Elias, 1991). The 1994 International Conference on Population and
Development held in Cairo, Egypt, strongly endorsed developing comprehensive,
integrated reproductive health services, of which cervical cancer prevention and
management should be an important component (United Nations, 1994). Linkage
between reproductive health services and the broader health care system also will be
essential; without cervical cancer control programs, some women inevitably will require
referral to tertiary facilities for major surgery or palliative care (Elias, 1991).
•
General physicians and non-physician providers should be trained to perform simple
outpatient CIN treatment (and screening). Non-clinicians also could be trained to do
history-taking and counseling of women being treated for CIN.
Having a broader pool of clinicians who are capable of providing screening and treatment
could significantly increase women’s access to appropriate and timely care, particularly
in non-urban areas. Survey results suggested that lack of trained personnel was a key
barrier to service delivery.
•
More limited, outpatient treatment methods (like cryotherapy and LEEP) are highly
effective, less expensive, safer, and more acceptable than inpatient methods such as cold
knife conization and hysterectomy.
Cold coagulation also could be considered. Unless clinically indicated, cold-knife cone
biopsy and hysterectomy should not be used as initial treatment methods for CIN,
although the survey clearly indicated that these are the only methods available in many
settings. The use of general anesthesia is usually not necessary for outpatient methods
and should be avoided to reduce costs and complication risks.
41
•
First priority should be given to treating all women with high-grade lesions.
Women with low-grade lesions should not be treated if resources for treating high-grade
lesions are not yet adequate (since the clinical benefit is much greater for those with
high-grade lesions) or if follow-up and monitoring for low-grade lesions is feasible
(since most will regress spontaneously). If follow-up is poor, women with low-grade
lesions can be treated as long as the needs of women with high-grade lesions are already
being adequately addressed. Survey results indicate that in many settings, all grades of
CIN generally are being treated. This may not be the best use of available resources.
•
Women, health care providers, key community leaders, and policy makers must
understand and support the cervical cancer control program for it to be effective.
Given the enormous competition for limited resources in many countries, political will to
undertake a cervical cancer prevention and control program is essential. Involving
women, health care providers, community leaders, and key policy makers in the
planning, implementation, and evaluation of the program helps ensure that potential
barriers are identified and realistic approaches are advocated.
Local Situation Review
As a first step in developing a plan of action (before national policies are changed and
detailed workplans are developed), several factors related to treatment must be reviewed and
additional data collected, if necessary. Existing data from health service statistics, cancer
registries, and studies such as the Demographic and Health Surveys should be helpful but
may need to be supplemented by compilations of various pathology records or other service
statistics or by qualitative research with clinicians, women, and other community members to
determine perceived need for services and identify important barriers to service delivery.
The key factors that must be clearly understood before proceeding with a plan of action fall
into three main areas: features of cervical disease; nature of existing health care resources
and constraints; and relevant characteristics of local women and their communities. Specific
information to be collected for each of these areas is detailed below:
Cervical disease
Number of CIN cases identified by existing screening services (or projected number, if
improvements in screening are being instituted)
• Estimated prevalence of CIN (by grade) and cancer
• Age distribution for CIN (by grade) and cancer
• Regional variations regarding incidence and prevalence of CIN and cancer within the
country
• Age-specific cervical cancer mortality rates
•
42
Existing health care resources and constraints
•
•
•
•
•
•
•
•
•
Number, type, and distribution of staff trained in performing screening and CIN
treatment
Type and distribution of health care facilities
Type of equipment available and capacity to maintain it
Systems and funding for essential supplies for providing CIN treatment
Record-keeping capacity; capacity for making and tracking referrals
Ability to follow up women after being screened or treated
Local health care costs and income (from budget allocations and/or fees); analysis of
competing demands for health funding
Analysis of existing health care settings (e.g., sterilization services, maternity hospitals)
to which cervical dysplasia treatment might be added
Availability of treatment services and palliative care for advanced cervical cancer
Characteristics of local women and their communities
• Age and geographic distribution of women
• Financial resources available for travel and treatment costs
• Prevalence of known or suspected risk factors (i.e., HPV or other STD infection,
smoking, high parity, high number of sexual partners or partner with lifetime high
number of partners, poor nutrition, oral contraceptive use)
• Knowledge, attitudes, and practices regarding cervical cancer and reproductive health
• Social constraints on the ability to seek medical care (such as need to seek husband’s
permission or manage other family responsibilities)
• Additional barriers to services as perceived by women.
Other site-specific issues also may need to be considered, but this general framework should
be useful in forming the basis of a plan of action.
The interplay of these various factors determines the uniqueness of each country’s situation
and will help suggest the appropriate set of options to be considered. For example, where
female sterilization services are established and have a high proportion of older clients, there
may be good opportunities to integrate cervical cancer screening and CIN treatment into
existing services and improve coverage of women at-risk. Worldwide, about six million
women per year seek voluntary surgical sterilization, of which 20 to 40 percent are 35 or
older, the appropriate age range for screening (AVSC International, 1994). Regions like
Latin America and Asia, in particular, both have high sterilization acceptance as well as high
cervical cancer rates. Technical and service delivery requirements for both surgical
sterilization and for CIN treatment overlap considerably; for example, much of the same
equipment and facility needs, as well as consumable supplies required for sterilization, also
are needed for outpatient CIN treatment (see chart, page 45). Still, to ensure optimal use of
resources, local programs must base their decision to integrate screening and treatment into
sterilization (or other) services on assessments of whether women seeking the existing
services in their settings are, in fact, at high risk for developing cervical cancer.
43
Developing and Implementing a Plan
Because of the focus of this document, this section is limited to a discussion of CIN
treatment only, but it is understood that any planning process for cervical cancer control must
be done in a larger context that includes screening, cancer treatment, and palliative care for
advanced cervical cancer. Where feasible, developing pilot projects based on this model
would be extremely useful. A diagram of a potential model for developing a comprehensive
plan for cervical cancer prevention and control, of which CIN treatment would be an
important component, is presented on page 47.
Key Components
Policies: Current policies must be articulated and modified as appropriate, along the lines
suggested in the ’’General Principles and Recommendations” (pages 40-42). Given the
survey’s findings, in many settings, policies affecting both treatment technologies and
diagnostic and treatment protocols should be reevaluated to determine if the most costeffective approaches are being supported. In countries where new protocols, such as the See
and Treat approach based on LEEP, could be adopted, policies regarding cytology,
colposcopy, and biopsy may have to be modified. Similarly, using a low-power
magnification device (should it prove feasible) instead of a colposcope to facilitate CIN
treatment also would require policy change. Policies will not be changed easily, however,
unless decision makers fully understand the health benefits and cost savings of introducing
new cervical cancer screening and treatment strategies.
Personnel: Any new plan must consider the issues of training existing staff, revising medical
and nursing curricula, reallocating staff time, and even redistributing staff geographically, in
some cases. Again, the survey points to the need, in particular, to improve training of
existing staff as well as expand training to non-physician providers to ensure cost-effective
coverage.
Equipment and Supplies: This is perhaps one of the biggest challenges to developing a
successful plan of action to improve cervical cancer prevention and control. Key issues that
must be addressed include type, number, maintenance and resupply, and distribution of
essential equipment and supplies. Cost, of course, is a primary limiting factor, but, as has
been demonstrated, selecting low-cost, outpatient methods over more expensive and
aggressive forms of treatment can result in considerable savings. Given that many settings
represented in the survey, particularly in Africa, are not equipped with colposcopes,
exploring alternative approaches to facilitating treatment (and/or screening) is strongly
recommended.
Community Involvement: Mechanisms to ensure community involvement, including local
government or nongovernment channels, must be included. Women and women’s health
advocacy groups, in particular, must be involved in developing a feasible and acceptable
plan. Without women’s support and understanding of the rationale for cervical cancer
prevention and control services, even an extremely well-planned program will fail.
44
Sterilization Services
Cervical Dysplasia
Treatment
Already
Required
Staff skills:
speculum exam
local anesthesia administration
cryotherapy or loop excision
equipment sterilization
Facilities:
clean, private exam room
Equipment
exam table
light
non-conductive speculum
magnifying device or colposcope
electrosurgical generator and loop equipment
or cryotherapy set
Supplies:
local anesthesia supplies
(needles, syringes, etc.)
liquid nitrogen or CO2 (cryo)
electrodes, loops, smoke evacuator
(loop excision)
antibiotics
/
Systems:
records
counseling
follow-up
ABVP1576
45
✓
Would Need
to be Added
Monitoring and Evaluation: Once a plan is implemented, monitoring and evaluation of key
components is essential to help guide the continuing development of these components and
to “fine-tune” the plan. In addition, evaluation indicators and mechanisms for ongoing
monitoring and impact assessment are essential to maintain political support and to ensure
efficient and effective program management. Both quantitative and qualitative indicators
should be derived from epidemiological, financial, and service delivery/quality of care data.
Costs: The costs and cost-effectiveness of planned treatment (and screening) interventions
must be well understood before a program is launched. Financial implications include
capital and recurrent budgets, whether locally or donor-financed, as well as issues of cost
recovery through patient fees. Every effort must be made to develop the most cost-effective,
yet efficacious program possible, and introducing low-cost CIN treatment methods will be
essential to the success of these efforts. In addition, decisions regarding what conditions to
treat and who can provide treatment will have profound effects on cost.
Process
Establishing a planning group: A planning group should be established that includes
representatives from at least clinical, epidemiology, health administration and financial
planning, and health education disciplines, as well as women and/or representatives from
women’s groups. Perspectives from medical/nursing education and research, procurement
and supplies, and health information systems also would be helpful. The process would start
with a consensus-building phase to determine goals and methods of introducing new CIN
treatment approaches. The local situation review, draft position papers on various policy
issues and strategies, technical information regarding new methods being considered, and
small meetings (including clinician and community consultation) should be used during this
phase. Considering cost-effectiveness of proposed approaches is essential, particularly if
major policy changes are recommended, since such concerns undoubtedly will play a large
role in how to allocate the limited resources available for cervical cancer prevention and
treatment. The draft plan must include a detailed timeline and budget.
Develop goals and objectives: Based on information from the local situation review and
other sources, a set of draft goals and objectives may be developed. This should be
considered a working document, which will be revised based on interactive feedback with
key groups and decision makers. The goals and objectives should include a proposed
geographic site for pilot introduction.
Consultation with key decision makers: Once consensus on a draft plan is achieved,
consultation with key decision makers is needed to build broad support for the plan and to
secure eventual approval. As part of these consultations, presentations could be made by the
planning group that strongly state the rationale for the program and include details about the
cost-effectiveness of the interventions proposed.
Consultation with other key groups: This would include a broader array of public- and
private-sector clinicians, women’s groups, researchers, educators, and other essential parties.
Before the plan is approved, consultation with these groups is essential to solicit feedback
46
Developing a Plan of Action to Control Cervical Cancer
Convene Local Planning Group
Other technical
information
Conduct Local Situation Review
♦ Features of cervical disease
♦ Existing health care resources and constraints
♦ Characteristics of local women and their
communities
Input from women,
community groups
I
Develop Goals and Objectives/Select Pilot Areas
_________i_________
Consult with Key Groups and Decision-Makers
4Resource Allocation
I
Policy change,
as needed
I
I
Develop Final Workplan
I
Prepare for Pilot Implementation
♦
♦
♦
♦
Equipment/supplies procurement
Staff training
Treatment protocol development
Establishment of information systems, etc.
4
------------------------- > Pilot Implementation
___________ 4
Interim progress reports
r_________ 4
Advisory groups, MOH
Adjust model, as needed
Evaluation
_________ 4_________
Develop Plan for Expanded Implementation
ABRP1561.PM5
47
4
and to gain their support, and materials appropriate to the particular audience should be
provided to contribute to their understanding of the plan being proposed. Based on the
feedback and support of these groups, the plan then can be modified, if necessary.
Development affinal workplan and preparation for implementation: Based on input from
key groups and decision makers, a final workplan can be developed. The workplan must
accurately reflect the resources available, and adjustments to the scope of work may be
necessary to stay within resource limits. The plan should have a phasing strategy built in
that, for example, gradually builds up services or extends them to different regions within the
country over a set period of time. A preparation phase for carrying out training, purchasing
needed equipment and supplies, and developing appropriate educational materials for clients,
care providers, and the community will be needed. Additional research, including operations
research to evaluate new strategies (such as the See and Treat approach or use of a lowpower magnification device), also may be part of the plan.
Pilot Implementation: Implementing the plan will be most successful if responsibility for it
is assigned to an individual or group with a high level of authority and credibility, as well as
personal interest in and commitment to the goal of cervical cancer control. Detailed annual
workplans, with periodic progress reviews by an advisory group, will help maintain
momentum and provide an opportunity to address unexpected obstacles or modify the plan in
the face of new information or circumstances. Information exchange between the
implementation team and key groups such as clinicians, women’s representatives,
community leaders, and decision makers will help the team be responsive to concerns as they
arise, maintain strong support for its efforts, and determine appropriate revisions to the
workplan.
Evaluation: Before proceeding with the next phase of implementation (expansion to other
areas or populations), an evaluation of the pilot effort is essential. Issues such as cost
effectiveness, staff training and technical skills, quality of care and health impact,
acceptability of new interventions to clients, maintenance of equipment and supplies, and
referral and follow-up systems must be carefully analyzed.
Innovative strategies
In addition to the guidelines and recommendations suggested earlier, several specific
strategies have been put forward for which additional data may be needed or that may be
appropriate only for particular situations. These include using an inexpensive, low-power
magnification device instead of a colposcope to facilitate biopsy sampling or LEEP
treatment; introducing the one- or two-visit See and Treat approach; using mobile teams
relying on aided visual inspection to provide follow-up assessments for women with lowgrade lesions, as well as to monitor those who have been treated for high-grade conditions
(visual screening also could be done); and using record cards retained by both women and
providers that document the date and results of either Pap smears or visual inspection as well
as recommended follow-up action. These suggestions are based on survey results and other
information that cited the inability to follow-up women, cost of equipment, prohibitive travel
48
costs for women, and lack of trained personnel, among others, as major barriers to CIN
treatment provision. In addition, strategies such as the use of mobile clinics could enable
monitoring rather than treatment of low-grade conditions (which seems to be widely
practiced and may be unnecessary).
CONCLUSIONS
The information gathered for this situation analysis clearly indicates that simple screening
methods must be coupled with low-cost, easy-to-use, and effective diagnostic and treatment
modalities to reduce cervical cancer morbidity and mortality and to reach more women at
risk. Survey results suggest that many countries do not have the resources to establish
effective cervical cancer control programs. Existing outpatient modalities such as
cryotherapy and LEEP are not widely available, and clinicians still must rely primarily on
cone biopsies and hysterectomies to treat CIN. Yet, women who are unscreened in these
countries risk eventually developing cervical cancer, and treatment for invasive conditions is
far more expensive than treatment of preinvasive disease. Cost analyses have demonstrated
that, depending on the prevalence of CIN, the cost per cervical cancer case averted through
appropriate management of preinvasive conditions is quite reasonable.
The survey also indicates that existing practices involving treatment of all CIN must be
reevaluated to ensure that the most rational, appropriate, and cost-effective CIN treatment
protocols are being used. In some settings, treating all grades, may, in fact, be the most
rational approach, but in many other settings, similar health benefits can be achieved at much
lower cost by treating only high-grade conditions with low-cost technologies.
Certainly, in some countries, the resources simply do not exist to initiate a comprehensive
cervical cancer screening and treatment program. Alternative strategies that match local
resources and epidemiology, however, may enhance the feasibility and cost-effectiveness of
expanding detection and treatment of preinvasive conditions. For example, should simple
screening approaches such as visual inspection prove accurate and feasible, early detection of
preinvasive lesions without cytology may become possible. Access to simple treatment also
may increase if low-power magnification could be used instead of colposcopy to facilitate
treatment. Furthermore, the strategy of screening only at-risk women (35-50 years old) and
treating only high-grade lesions may reduce the burden on health care facilities, while still
achieving public health benefit. Finally, integrating treatment services into existing
programs such as sterilization clinics may reduce costs. In any case, cervical cancer
prevention and control strategies must be tailored to local situations and needs, particularly
where resources are limited, to ensure that they are cost-effective and successful.
Governmental agencies, donor organizations, as well as program managers should work to
initiate and support efforts to determine the prevalence of cervical cancer in their settings. A
local situation review, as previously described, is a key first step to developing a plan of
action. With the advent of low-cost, effective CIN treatment technologies, as well as
ongoing research regarding alternative screening approaches, cervical cancer prevention and
control eventually may be within the grasp of even the most financially strapped countries.
49
Glossary
Adenocarcinoma: A malignant neoplasm primarily consisting of glandular epithelium.
Adenocarcinoma accounts for approximately 5 percent of cervical cancer cases worldwide.
Aided visual inspection (AVI): Visualization of the cervix using a portable, low-power
magnification device (as opposed to a colposcope) and acetic acid to facilitate cervical
cancer screening (and/or possibly to guide biopsy and outpatient treatment of preinvasive
lesions).
Acetic acid: A vinegar solution that is applied to cervical tissue to facilitate identification of
abnormal tissue. The acetic acid interacts with diseased cells, causing epithelial lesions to
turn white.
Bethesda Classification System: Proposed in 1988 by the U.S. National Cancer Institute,
this system relies on only two grades for reporting cervical cancer precursor conditions:
low-grade squamous intraepithelial lesions (SIL), which include cellular atypia and CIN I,
and high-grade squamous intraepithelial lesions, which include CIN II, III and CIS. The
system creates uniform terminology, includes a statement regarding the adequacy of the
cytological specimen, and uses subcategories to further describe cytologic changes.
Cervical stenosis: A narrowing of the cervical canal.
Cervical Intraepithelial Neoplasia (CIN) Classification System: Introduced in the 1960s,
the CIN classification system for reporting cytological (Pap smear) results grades the
severity of cervical lesions so that mild cervical dysplasia was categorized as CIN I;
moderate cervical dysplasia as CIN II; and severe cervical dysplasia as CIN III.
Carcinoma in situ (CIS): Cellular changes in the stratified squamous epithelium associated
with invasive cancer but not extending to adjacent structures. CIS is generally a
recognizable precursor of invasive squamous cell cancer.
Coagulation: The process of clotting blood and contracting the ends of blood vessels to
cause bleeding to stop. Electrosurgically, the type of current that promotes coagulation.
Cold coagulation: The use of a thermal probe heated to 100° C to destroy abnormal
cervical tissue.
Colposcopy: Examination of the vagina and cervix using an endoscopic instrument
(colposcope) that provides magnification to allow direct observation and study of vaginal
and cervical cells in vivo.
Cold knife cone biopsy (also known as conization): A surgical procedure to obtain a cone
of endocervical tissue with a cold knife blade so as to preserve the tissue’s histological
characteristics for histopathologic analysis.
50
Cryotherapy: The use of extremely low temperatures (-60° C to -90° C) to freeze and
destroy abnormal tissue.
Cytology: The study of the anatomy, physiology, pathology, and chemistry of the cell, such
as those associated with the endo- and ecto-cervix.
Diathermy: The generation of heat resulting from the passage of a high-frequency electric
current.
Dysplasia of the uterine cervix: Epithelial abnormality involving part of the cervical
squamous epithelium.
Electrode: The terminal of an electric circuit through which electrons pass.
Electrocautery (electrocoagulation): The process of using an electrically heated metal
probe reaching very high temperatures to destroy abnormal tissue.
Ectocervix: The external portion of the uterine cervix and os.
Endocervix: The mucous membrane of the cervical canal.
Gynoscope: One version of an experimental, low-power (2.5x) magnification device that
may be useful in visual inspection of the cervix (in conjunction with acetic acid) to facilitate
cervical cancer screening and, perhaps, to guide biopsy and treatment of preinvasive disease.
Further evaluation of the gynoscope or a similar device is necessary to validate these
potential applications.
Loop Electrosurgical Excision Procedure (LEEP): Also known as large loop excision of
the transformation zone (LLETZ), LEEP is a method of outpatient excisional biopsy and
treatment that is used to remove the entire transformation zone using a thin wire electrode
charged with a low-voltage, high-frequency alternating current (600kHz), producing a tissue
specimen for histologic analysis.
Microinvasion: Invasion of tissue immediately adjacent to a carcinoma in situ’, the earliest
stage of malignant neoplastic invasion.
Punch biopsy: A method by which a small sample of tissue is extracted for histological
analysis.
Return electrode (or patient return electrode): The electrode that directs electrical
current flow from the patient back to the generator during electrosurgery.
Squamocolumnar junction: The point at which columnar cells meet ectocervical
squamous cells on the cervix. This junction is located in the center of the transformation
zone and is most vulnerable to abnormal changes in cervical cells.
51
Transformation zone: Located at the entrance to the endocervical canal, the transformation
zone is surfaced with glandular (columnar) epithelium until the onset of puberty, when the
glandular epithelium is gradually replaced by squamous epithelium, similar to the lining of
the vagina. Cervical cancer generally originates in the transformation zone.
Unaided visual inspection (UVI): Visualization of the cervix without magnification (but
with acetic acid) to screen for cervical cancer.
52
BIBLIOGRAPHY
American College of Obstetrics and Gynecology (ACOG) Technical Bulletin. Cervical
cytology: evaluation and management of abnormalities. International Journal of
Gynecology and Obstetrics 43:212-220, 1993.
Andersen ES, Husth M. Cryosurgery for cervical intraepithelial neoplasia: 10-year follow
up. Gynecologic Oncology 45:240-242, 1992.
Apgar BS, Wright TC, Pfenninger JL. Loop electrosurgical excision procedure for CIN.
American Family Physician 46(2):505-518, 1992.
Arof HM, Gerbie MV, Smeltzer J. Cryosurgical treatment of cervical intraepithelial
neoplasia: four-year experience. American Journal of Obstetrics and Gynecology
150(7):865-869, 1984.
AVSC International, personal communication, June 1994.
Benedet JL, Nickerson KG, Anderson GH. Cryotherapy in the treatment of cervical
intraepithelial neoplasia. Obstetrics and Gynecology 58:725, 1981.
Benrubi GI, Young M, Nuss RC. Intrapartum outcome of term pregnancy after cervical
cryotherapy. Journal of Reproductive Medicine 29(4):251-254, 1984.
Berget A, Andreasson B, Bock JE. Laser and cryosurgery for cervical intraepithelial
neoplasia. Acta Obstetrics and Gynecology Scandinavia 70:231-235, 1991.
Bigrigg MA, Codling BW, Pearson P, Read MD Swingler GR. Colposcopic diagnosis and
treatment of cervical dysplasia in one visit. The Lancet 336:229-231, July 28, 1990.
Bigrigg MA, Haffenden DK, Sheehan AL, Codling BW, Read MD. Efficacy and safety of
large-loop excision of the transformation zone. The Lancet 343:32-34, January 1, 1994.
Blumenthal P, Gaffikin L, Maier NM, Riseborough P (eds). Issues in Cervical Cancer
Screening: Seeking Alternatives to Cytology (Workshop Proceedings). Johns Hopkins
Program for International Education in Reproductive Health (JHPIEGO Corporation), March
2-4, 1994.
Bosch FX, Castellsague X. Prevention of cervical cancer in developing countries:
intervention trial proposal (second draft), 1994.
Bryson SC, Lenehan P, Lickrish GM. The treatment of grade 3 cervical intraepithelial
neoplasia with cryotherapy: an 11-year experience. American Journal of Obstetrics and
Gynecology 151:201-206, 1985.
53
Chamberlain J. Reasons that some screening programmes fail to control cervical cancer.
In: Screening for Cancer of the Uterine Cervix, M. Hakama et al (eds). Lyon: International
Agency for Research on Cancer (IARC) Scientific Publication No. 76:161-168, 1986.
Chanen W. The efficacy of electrocoagulation diathermy performed under local anesthesia
for the eradication of precancerous lesions of the cervix. New Zealand Journal of Obstetrics
and Gynecology 29: 3(1): 189-192, 1989.
Chappatte OA, Byrne DL, Raju KS, NayagSm M, Kenney A. Histological differences
between colposcopic-directed biopsy and loop excision of the transformation zone (LETZ):
a cause for concern. Gynecologic Oncology 43:46-50, 1991.
Creasman WT, Clarke-Pearson DL, Weed JC. Results of outpatient therapy of cervical
intraepithelial neoplasia. Gynecologic Oncology 12:S306-S316, 1981.
Creasman WT, Hinshaw WM, Clarke-Pearson DL. Cryosurgery in the management of
cervical intraepithelial neoplasia. Obstetrics and Gynecology 63(2): 145-149, 1984.
Deigan E, Carmichael JA, Ohlke ID, Karchmar J. Treatment of cervical intraepithelial
neoplasia with electrocautery: a report of 776 cases. American Journal of Obstetrics and
Gynecology 154(2):255-259, 1986.
Draeby-Kristiansen J, Garsaae M, Bruun M, Hansen K. Ten years after cryosurgical
treatment of cervical intraepithelial neoplasis. American Journal of Obstetrics and
Gynecology 165(l):43-45, 1991.
Editorial. Large loop excision of the transformation zone. The Lancet 337:148, January 19,
1991.
Elias, C. STDs and the Reproductive Health of Women in Developing Countries. Program
Division Working Papers, No. 5. New York: The Population Council, 1991.
Ferenczy A. Comparison of cryo- and carbon dioxide laser therapy for cervical
intraepithelial neoplasia. Obstetrics and Gynecology 66(6): 793-798, 1985.
Fruchter RG, Maiman M, Sillman FH, Camilien L, Webber CA, Kim DS. Characteristics of
cervical intraepithelial neoplasia in women infected with the human immunodeficiency
virus. American Journal of Obstetrics and Gynecology 171(2):531-537, 1994.
Giles J A, Gafar A. The treatment of CIN: do we need lasers? British Journal of Obstetrics
and Gynecology 98:3-6, 1991.
Gordon H, Duncan I. Effective destruction of cervical intraepithelial neoplasia (CIN) 3 at
100 degrees using the Semm cold coagulator: 14 years experience. British Journal of
Obstetrics and Gynecology 98:14-20, 1991.
54
Guijon, F, Paraskevas, M, McNicol, P. Human papillomavirus infection and the size and
grade of cervical intraepithelial neoplastic lesions associated with failure of therapy.
International Journal of Gynecology and Obstetrics 42: 137-142, 1993.
Gunasekera PC, Phipps JH, Lewis B V. Large loop excision of the transformation zone
(LLETZ) compared to carbon dioxide laser in the treatment of CIN: a superior mode of
treatment. British Journal of Obstetrics and Gynecology 97:995-998, 1990.
Hemmingson E, Stendahl U, Stenson S. Cryosurgical treatment of cervical intraepithelial
neoplasia with follow up of five to eight years. American Journal of Obstetrics and
Gynecology 139(2): 144-147, 1981.
Howe DT, Vincenti AC. Is large loop excision of the transformation zone (LLETZ) more
accurate than colposcopically directed punch biopsy in the diagnosis of cervical
intraepithelial neoplasia? British Journal of Obstetrics and Gynecology 98:588-591, 1991.
Jamison DT, Moseley WH (eds). Disease Control Priorities in Developing Countries.
Washington, DC: World Bank, Population, Health, and Nutrition, 1990.
Keijser KGG, Kenemans P, van der Zanden P, Schijf CPT, Vooijs P, Rolland R. Diathermy
loop excision in the management of cervical intraepithelial neoplasia: diagnosis and
treatment in one procedure. American Journal of Obstetrics and Gynecology 166(4): 1281 1287, 1992.
Koutsky L, Kiviat N. Specific human papillomavirus types as the causal agents of most
cervical intraepithelial neoplasia: implications for current views and treatment. Journal of
the National Cancer Institute 85(12):934-935, 1993.
Loobuyck H, Duncan I. Destruction of CIN 1 and 2 with the Semm cold coagulator: 13
years’ experience with the see-and-treat policy. British Journal of Obstetrics and
Gynecology 100:465-468, 1993.
Luesley DM, Cullimore J, Redman CWE, Lawton FG, Emens JM, Rollason TP, Williams
DR, Buxton EJ. Loop diathermy excision of the cervical transformation zone in patients
with abnormal cervical smears. British Medical Journal 300:1690-1693, 1993.
Luthra UK, Rengachari R. Organization of screening programmes in developing countries
with reference to screening for cancer of the uterine cervix in India. In: Reproductive Tract
Infections, A. Germain (ed). New York: International Women’s Health Coalition, 1993.
Machoki JMN, Rogo KO. Knowledge and attitudinal study of Kenyan women in relation to
cervical carcinoma. International Journal of Gynecology and Obstetrics 34:55-59, 1990.
55
Maiman M, Fruchter RG, Serrrur E, Levine PL, Arrastia C, Sedlis A. Recurrent cervical
intraepithelial neoplasia in human immunodeficiency virus-seropositive women. Obstetrics
and Gynecology 82:170-174, 1993.
Mayeaux EJ, Harper MB. Loop electrosurgical excision procedure. The Journal of Family
Practice 36(2):214-219, 1993.
Miller AB. Cervical Cancer Screening Programmes: Managerial Guidelines. Geneva:
World Health Organization, 1992.
Monaghan JM, Kirkup W. Treatment of cervical intraepithelial neoplasia by colposcopically
directed cryosurgery and subsequent pregnancy experience. British Journal of Obstetrics
and Gynecology 89:387-392, 1982.
Montz FJ, Holdschneider CH, Thompson LDR. Large-loop excision of the transformation
zone: effect on the pathologic interpretation of resection margins. Obstetrics and
Gynecology 81(6):976-982, 1993.
Mor-Yosef S, Lopes A, Pearson S, Monoghan J. Loop diathermy cone biopsy. Obstetrics
and Gynecology 75(5):884-886, 1990.
Nasiell K, Roger V, Nasiell M. Behavior of mild cervical dysplasia during long-term follow
up. Obstetrics and Gynecology 67:665-669, 1986.
Olatunbosun OA, Okonofua FA, Ayangade SO. Outcome of cryosurgery for cervical
intraepithelial neoplasia in a developing country. International Journal of Obstetrics and
Gynecology 38:305-310, 1992.
Parkin DM, Pisani P, Ferlay J. Estimates of the worldwide incidence of eighteen major
cancers in 1985. International Journal of Cancer 54:594-606, 1993.
Petterson F. (ed). Annual Report on the Results of Treatment in Gynecological Cancer.
International Federation of Gynecology and Obstetrics, Stockholm, Sweden, 1985.
Prendiville W, Cullimore J, Normal S. Large loop excision of the transformation zone
(LLETZ). A new method of management for women with cervical intraepithelial neoplasia.
British Journal of Obstetrics and Gynecology 96: 1054-1060, 1989.
Rattray C, DaCosta V, Chatoor J, Mullings A, Wynter DM, Wynter HH. Large loop excision
of the transformation zone (LLETZ): an alternative treatment for cervical intraepithelial
neoplasia. West Indies Medical Journal 42:62-46, 1993.
Richart RM, Townsend DE, Crisp W, DePetrillo A, Ferenczy A, Johnson G, Lickrish G, Roy
M, Villa Santa U. An analysis of “long-term” follow-up results in patients with cervical
intraepithelial neoplasia treated by cryotherapy. American Journal of Obstetrics and
Gynecology 137(7):823-826, 1980.
56
Richart R, Wright T. Controversies in the management of low-grade CIN. Cancer
71(4): 1413-1421, February 15, 1993.
Richart R. Personal communication, 1995.
Rogo KO. The gynoscope: can it replace the colposcope in a developing country setting?
Paper presented at the XIX Annual Scientific Conference of the Kenya Obstetricians and
Gynecologists Society. Nairobi, Kenya, February 1995.
Rogo KO, Omany J, Onyango JN, Ojwang SB, Stendahl U. Carcinoma of the cervix in an
African setting. International Journal of Obstetrics and Gynecology 33:249-255, 1990.
Saidi MH, Akright BD, Seltzer FD, Sadler RK, Farhat SA. Diagnostic and therapeutic
conization using loop radiothermal cautery. Journal of Reproductive Medicine 38(10):776779, 1993.
Sammarco MJ, Hartenbach EM, Hunter VJ. Local anesthesia for cryosurgery on the cervix.
The Journal of Reproductive Medicine 38(3): 170-172, 1993.
Schantz A, Thormann L. Cryosurgery for dysplasia of the uterine cervix. Acta Obstetrics
and Gynecology Scandinavia 63:417-420, 1984.
Schuurmans S, Ohlke ID, Carmichael, JA. Treatment of cervical intraepithelial neoplasia
with electrocautery: report of 426 cases. American Journal of Obstetrics and Gynecology
148(5):544-546, 1984.
Schiffman MH, Bauer HM, Hoover RN, Glass AG, Cadell DM, Rush BB, Scott DR,
Sherman ME, Kurman RJ, Wacholder S, Stanton CK, Manos MM. Epidemiologic evidence
showing that human papillomavirus infection causes most cervical intraepithelial neoplasia.
Journal of the National Cancer Institute 85(12):958-964, 1993.
Singh V, Seghal A, Luthra U. Management of dysplasia and carcinoma in situ cases and
their outcome during long-term follow-up. Journal of Obstetrics and Gynecology of India
1991.
Sherris J, Wells E, Tsu V, Bishop A. Cervical Cancer in Developing Countries: A Situation
Analysis. Women’s Health and Nutrition Working Paper, The World Bank, 1993.
Sjamsuddin S, Prihartono J, Nuranna L, Mulyanto W. Endardjo S, Aziz MF, Comain S,
Luwia M. Aided visual inspection; preliminary results of the Indonesian gynoscope
assessment. In: Proceedings for a Working Meeting on Cervical Cancer Prevention,
Screening, and Treatment. Program for Appropriate Technology in Health (PATH) and
AVSC International, Montreal, Quebec, September 1994.
Spinillo A, Tenti P, Rao S, Zappatore R, Romagnoli S, Pizzoli G. Nucleolar organizer
regions and cervical intraepithelial neoplasia among women with human immunodeficiency
virus infection. American Journal of Obstetrics and Gynecology 171:773-777, 1994.
57
Townsend DE. Cryosurgery for CIN. Obstetrical and Gynecological Survey 34:828, 1979.
Townsend DE, Richart RM. Cryotherapy and carbon dioxide laser management of cervical
intraepithelial neoplasia: a controlled comparison. Obstetrics and Gynecology 61(l):75-78,
1983.
United Nations. Report of the International Conference on Population and Development,
September 5-13, 1994, Cairo, Egypt. New York: United Nations, 1994.
VasquezF. Personal communication, 1994.
Warren DL, Duerr, A. HIV infection in non-pregnant women: a review of current
knowledge. Current Opinion in Obstetrics and Gynecology 5:527-533, 1993.
Wetchler SJ. Treatment of cervical intraepithelial neoplasia with the CO2 laser: laser versus
cryotherapy. A review of effectiveness and cost. Obstetrical and Gynecological Survey
39(8):469-473, 1984.
Williams OE, Bodha M, Alawattegama AB. Outcome of cold coagulation for the treatment
of cervical intraepithelial neoplasia in a department of genitourinary medicine.
Genitourinary Medicine 69:63-65, 1993.
World Health Organization. Control of cancer of the cervix uteri: a WHO meeting. Bulletin
of the World Health Organization 64(4):607-618, 1986.
World Health Organization. National Cancer Control Programmes: Policies and
Managerial Guidelines. Geneva: WHO, 1995.
Wright TC, Gagnon S, Richart R, Ferenczy A. Treatment of cervical intraepithelial neoplasia
using the loop electrosurgical excision procedure. Obstetrics and Gynecology 79(2): 173178, 1992a.
Wright TC, Richart RM, Ferenczy A. Electrosurgery for HPV-related Diseases of the Lower
Genital Tract: A practical handbook for diagnosis and treatment by electroexcision and
fulguration procedures. BioVision, Inc., Montreal and Arthur Vision, Inc., New York, 1992b.
Wright VC, Davies EM. The conservative managementof cervical intraepithelial neoplasia:
the use of cryosurgery and the carbon dioxide laser. British Journal of Obstetrics and
Gynaecology 88:663-668, 1981.
ABRP1545.PM5
58
Appendix A
CERVICAL CANCER SCREENING: KEY ISSUES
Screening and treatment clearly are interdependent and cannot be addressed in isolation of
one another. Below is a brief review of the key issues related to screening:
Screening Strategies
Screen only older women: To be most efficient and effective, cervical cancer screening in
low-resource settings should focus on women age 35 and older. Data suggest that the
incidence of cervical cancer peaks in women age 40 to 50; therefore, initiating screening
among younger women will result in only a slight change in disease incidence but will cause
a substantial increase in costs.
Screen infrequently: Screening should be performed relatively infrequently such as once
every five to ten years. Indeed, screening women even once in their lifetime prevents many
more cases of cervical cancer than screening a small proportion of women every few years.
Use simple screening technologies: Investigations are underway on several innovative
approaches to screen for cervical cancer that may be particularly appropriate for lowresource settings. The standard screening approach as well as several innovative approaches
are described below.
Screening Technologies
Cytology: The standard approach to cervical cancer screening relies on cytology (the
Papanicolaou or “Pap” smear). Cervical cells are scraped from the cervix, fixed on a slide,
and analyzed using a microscope to determine the presence or absence of cancerous or
precancerous conditions. In many settings, however, cytology-based screening is impossible
to implement given clinical, laboratory, financial, and other logistics requirements.
Visual screening: One promising alternative approach to screening is visual inspection of the
cervix during a speculum exam. Several variations of visual inspection currently are being
evaluated:
• Downstaging: Visual inspection of an untreated cervix to detect signs of early cancer.
• Unaided visual inspection (UVI): Visual inspection of a cervix treated with acetic acid (a
vinegar solution which turns lesions white) to detect high-grade dysplasia.
• Aided visual inspection (AVI): Visual inspection of an acetic-acid treated cervix using a
small, lightweight, low-power magnifying device to detect high-grade dysplasia.
Cervicography. Currently used in several countries, cervicography relies on a camera to
photograph the cervix. These photographs are later projected as slides and examined for
abnormalities.
A-l
Automated Pap screening: This approach relies on machines, currently being developed and
tested, that will evaluate cervical cytology slides. Standard cytology methods then would be
used only to confirm positive slides.
HPV screening: Suggested approaches to HPV screening include concurrent HPV and Pap
screening to identify women who have both an abnormal Pap smear and are infected with
high-risk types of HPV, and HPV screening first to determine which women should
receive Pap smears or further evaluation. Currently, however, HPV testing is very expensive
and generally is used for research only.
HPV Vaccine: Research currently is underway to develop a vaccine that would prevent
infection with HPV (therefore preventing most cervical cancer). Such a vaccine is unlikely
to be available for many years, however.
(For more detailed descriptions of these approaches, see Cervical Cancer in Developing
Countries: A Situation Analysis by J. Sherris et al, World Bank, 1993, which is available
from PATH).
A-2
Appendix B
REGIONAL RETURN RATES AND LIST OF COUNTRIES
REPRESENTED IN THE SURVEY
Return Rate by Region
Region*
Return rate
Africa
Asia
Latin America
The Caribbean
Middle East
Former Soviet Union
43% (41/96)
60% (35/58)
22% (8/36)
46% (16/35)
72% (8/11)
100% (2/2).
TOTAL
46% (110/238)
Countries Represented in the Survey
Africa
Asia
Latin America
Caribbean
Burkina Faso
Cameroon
Ethiopia
Ghana
Kenya
Malawi
Nigeria
Sierra Leone
South Africa
Uganda
Zambia
Zimbabwe
India
Indonesia
Philippines
Thailand
Vietnam
Argentina
Brazil
Chile
Costa Rica
Nicaragua
Middle East
Former Soviet Union
Turkey
Russia
Armenia
Anguilla
Antigua
Barbados
Dominican Republic
Jamaica
Monserrat
Trinidad & Tobago
St. Vincent & Grenadines
*There was particularly strong representation from Kenya (about 11 percent of the total) as well as from
Sierra Leone, Thailand, and the Philippines (9 to 10 percent each of the total). This may be due to the
presence of PATH field offices or associates in these countries.
B-l
Appendix C
CALCULATING TREATMENT COSTS
Introduction
The following examples are intended to demonstrate a possible approach for calculating costs
associated with CIN treatment. Hypothetical examples are included for cryotherapy and LEEP,
for which values have been estimated. In addition, country examples (Thailand and Zimbabwe)
are included for each of these methods. Since cost information for these countries was incom
plete, certain values such as salaries and consumable supplies had to be estimated. In addition,
because these examples do not include screening-related costs, which would be required to
calculate true costs of cervical cancer prevention and control activities, readers should focus on
the process of calculating CIN treatment costs rather than on the outcome.
Key Inputs
To calculate treatment-related costs, information on local cervical dysplasia and cancer epidemiol
ogy as well as on capital and recurrent treatment costs is needed.
Epidemiology and service provision: In the following examples, several assumptions are made
that affect costs per dysplasia case treated or cancer case averted. For instance, calculations are
based on treating only those women who were screened and correctly identified as requiring
treatment both initially and during post-treatment follow-up. At-risk women who remained
unscreened or those who were incorrectly classified are not included. This was done because
additional treatment costs resulting from screening inaccuracy (which greatly affect costs per case
treated) are really screening rather than treatment costs and are not the focus here. Therefore, in
order to limit the focus to treatment costs for this demonstration, it was assumed that 100 percent
of at-risk women would be screened and that Pap smears were 100 percent sensitive in detecting
dysplasia, both on initial screening and as part of post-treatment evaluation (see box, page 38).
The rate of cryotherapy-associated treatment complications was assumed to be 1 percent, while
the rate of LEEP-associated complications was assumed to be 1.5 percent.
Several key factors affect treatment cost:
• Treatment cure rate: For cryotherapy, the cure rate for high-grade CIN was assumed to be 85
percent, while for LEEP, it was assumed to be 95 percent.
• Prevalence of high-grade CIN: In the two country examples, the difference in total program
costs is largely attributable to the difference in prevalence, since other costs are quite similar.
• Progression rate of high-grade CIN to cancer: In these examples, the progression rate was
assumed to be 50 percent, although, in reality, this rate would be greatly influenced by the
proportion of the CIN II (versus CIN III/CIS) in the population. In largely unscreened popula
tions, it can be assumed that the progression rate would be higher than in screened populations
since CIN III prevalence is likely to be high. As screening coverage expands, the progression
rate would begin to decline, while the costs per cancer case averted would begin to rise.
Capital and recurrent costs: Capital costs are spread over the life of the investment, which has
been set arbitrarily at five years for these examples. Recurrent costs include consumable sup
plies, as well as costs associated with follow-up therapy of treatment failures arid/or complications.
C-l
Hypothetical Example
Cryotherapy Costs
Assumptions
I. Epidemiology and Service Provision
A. Total population at risk
B. Prevalence of CIN n+ in population
C. Proportion of untreated CIN 11+ progressing to Ca
D. Proportion of at-risk population screened/year
E. Proportion of CIN 11+ detected by screening test
F. Proportion of normal cervices classified correctly
G. Primary treatment success rate
H. Proportion of cases of treatment failure detected
during follow-up
I. Follow-up treatment success rate
250,000
1.5%
50%
100%*
100%*
100%*
85%
100%*
95%
IL Expected cases and outcomes
J. Expected CIN cases(A x D x B x E)
primary treatment
250,000 x 1.00 x .015 x 1.00 = 3,750
K. Expected CIN casesfollow-up treatment
(1-G) x J x H
(l-.85)x 3,750 x 1.00 = 563
L. Cancer cases averted
C x [(J x G) + (K x I)]
.50 x [(3,750 x .85) + (563 x .95)] = 1,862
M. Cancer cases missed due
to ineffective treatment
J x C x [(1-G) x (1-H) + (1-G) x H x (1-1)]
3,750 x .50 x [(1-.85) x (1-1.00) + (1-.85) x 1.00 x (1 -.95)] = 14
N. Cases of treatmentassociated complications
(Jx 1%)
(3,750 x .01) = 38
III. Cost Calculations
Capital Costs
Equipment
Training
Refrigerant
Costs per 1,000
women treated
Total (for
3,750 cases)
$2,000 (1 cryotherapy unit) $8,000
$750 (2 people)
$3,000
$500 (2 tanks)
TOTAL
*See box, page 38
C-2
Amortized
(5 years)
$1,600
$2,000
$600
$400
$13,000
$2,600
Costs per 1,000
women treated
Total (for
3,750 cases)
Salaries
(1 FTE**/l,000 cases)
$6,000
$24,000
Supplies
($5/case treated)
$5,000
$18,750
Recurrent Costs
Follow-up of ineffective treatment
($100/cone biopsy xK)
$56,300
Treatment complications
($50/complication x N)
$1,900
Treatment of cancer
($1,500/hysterectomy x M)
$21,000
TOTAL
$121,950
Total Annualized Treatment Costs
$121,950 + $2,600 = $124,550
Total Costs Per CIN Case Treated***
Total Costs + J
$124,550 + 3,750 = $33
Total Costs Per Cancer Case Averted***
Total Costs + L
$124,550 + 1,862 = $67
**FTE = Full-time equivalent
***Not including screening costs.
C-3
Hypothetical Example
LEEP Costs
Assumptions
I. Epidemiology and Service Provision
A. Total population at risk
B. Prevalence of CIN 11+ in population
C. Proportion of untreated CIN 11+ progressing to Ca
D. Proportion of at-risk population screened/year
E. Proportion of CIN 11+ detected by screening test
F. Proportion of normal cervices classified correctly
G. Primary treatment success rate
H. Proportion of cases of treatment failure detected
during follow-up
I. Follow-up treatment success rate
250,000
1.5%
50%
100%*
100%*
100%*
95%
100%*
95%
II. Expected cases and outcomes
J. Expected CIN cases(A x D x B x E)
primary treatment
250,000 x 1.00 x .015 x 1.00 = 3,750
K. Expected CIN casesfollow-up treatment
(1-G) x J x H
(l-.95)x 3,750 x 1.00 = 188
L. Cancer cases averted
C x [(J x G] + (K x I)]
.50 x [(3,750 x .95) + (188 x .95)] = 1,871
M. Cancer cases missed due
to ineffective treatment
J x C [(1-G) x (1-H) + (1-G) x H x (1-1)]
3,750 x .50 x [(1-.95) x (1-1.00) + (1-.95) x 1.00 x (1-.95) = 5
N. Cases of treatmentassociated complications
(Jx 1.5%)
(3,750 x .015) = 56
III. Cost Calculations
Capital Costs
Costs per 1,000
women treated
Total (for
3,750 cases)
Equipment
$6,000 (LEEP unit)
$24,000
$4,800
Training
$950 (2 people)
Other
$20,000 (colposcope)
$3,800
$80,000
$760
$16,000
TOTAL
$26,950
$107,800
$21,560
*See box, page 38
C-4
Amortized
(5 years)
Costs per 1000
women treated
Total (for
3,750 cases)
Salaries
(1 FTE^/1,000 cases)
$8,000
$32,000
Supplies
($25/case treated)
$25,000
$93,750
Recurrent Costs
Follow-up of ineffective treatment
($100/cone biopsy x K)
$18,800
Treatment complications
($50/complication x N)
$2,800
Treatment of cancer
($1,500/hysterectomy x M)
$7,500
TOTAL
$154,850
Total Annualized Treatment Costs
$154,850 + $21,560 = $176,410
Total Costs Per CIN Case Treated***
Total Costs + J
$176,410 + 3,750 = $47
Total Costs Per Cancer Case Averted***
Total Costs + L
$176,410 + 1,871 = $94
**FTE = Full-time equivalent
***Not including screening costs.
C-5
Country Example
Urban Facility in Thailand*
Assumptions
I. Epidemiology and Service Provision
A. Total population (# of clients) at risk
B. Prevalence of CIN n+ in population
C. Proportion of untreated CIN n+ progressing to Ca
D. Proportion of at-risk population screened/year
E. Proportion of CIN 11+ detected by screening test
F. Proportion of normal cervices classified correctly
G. Primary treatment success rate
H. Proportion of cases of treatment failure detected
during follow-up
I. Follow-up treatment success rate
II. Expected Cases and Outcomes
J. Expected CIN cases-primary treatment
K. Expected CIN cases-follow-up treatment
L. Cancer cases averted
M. Cancer cases missed due to ineffective treatment
N. Cases of treatment-associated complications
Ill.Cost Calculations (annualized costs)
Capital Costs
Equipment
Training (1 person)
Other (refrigerant tanks, colposcope)
Recurrent Costs
Salaries
Supplies
Follow-up of ineffective treatment
Treatment complications
Treatment of cancer
Total Annualized Treatment Costs
Total Costs Per CIN Case Treated***
Total Costs Per Cancer Case Averted***
24,000
0.3%
50%
100%**
100%**
100%**
Cryotherapy
85%
100%**
LEEP
95%
100%**
95%
95%
72
11
36
0
1
72
4
36
0
1
$400
$300
$100
$1200
$380
$4,000
$8,000
$2,880
$660
$50
0
$8,000
$3,384
$240
$50
0
$12,390
$172
$344
$17,254
$240
$479
*The values used in this example are either derived from cost information gathered on the surveys, or they are esti
mated for the purposes of demonstration. The final calculations, therefore, should be considered only as illustrative.
**See box, page 38.
***Not including screening costs.
C-6
Country Example
Urban Facility in Zimbabwe*
Assumptions
I. Epidemiology and Service Provision
A. Total population (# of clients) at risk
B. Prevalence of CIN n+ in population
C. Proportion of untreated CIN n+ progressing to Ca
D. Proportion of at-risk population screened/year
E. Proportion of CIN 11+ detected by screening test
F. Proportion of normal cervices classified correctly
G. Primary treatment success rate
H. Proportion of cases of treatment failure detected
during follow-up
I. Follow-up treatment success rate
II. Expected Cases and Outcomes
J. Expected CIN cases-primary treatment
K. Expected CIN cases-follow-up treatment
L. Cancer cases averted
M. Cancer cases missed due to ineffective treatment
N. Cases of treatment-associated complications
IILCost Calculations (annualized costs)
Capital Costs
Equipment
Training (1 person)
Other (colposcope, refrigerant tank)
Recurrent Costs
Salaries
Supplies
Follow-up of ineffective treatment
Treatment complications
Treatment of cancer
Total Annualized Treatment Costs
Total Costs CIN Per Case Treated***
Total Costs Per Cancer Case Averted***
3,000
6%
50%
100%**
100%**
100%**
Cryotherapy
85%
100%**
LEEP
95%
100%**
95%
95%
180
27
90
1
2
180
9
90
0
3
$400
$300
$100
$1,200
$380
$4,000
$6,000
$7,280
$1,620
$100
$200
$6,000
$9,900
$540
$150
0
$15,800
$88
$176
$22,170
$123
$246
*The values used in this example are either derived from cost information gathered on the surveys, or they are esti
mated for the purposes of demonstration. The final calculations, therefore, should be considered only as
illustraative.
**See box, page 38.
***Not including screening costs.
C-7
TECHNICAL INFORMATION
More than 40% of the women reporting to the Kidwai Memorial Institute of Oncology
suffer from a gynaecological cancer.
i
Cancer of the cervix ( one of the gynaecological cancers ) is the most common cancer
affecting the Indian women. A review of the case records of 6941 women with cancer
cervix revealed that majority are from rural areas, they ( 83.6% ) are aged between 35
and 64 years and 97.1% report for treatment with disease that has spread beyond the
cervix. Lack of awareness about the symptoms of the disease (57.6%) and lack of adequate
advice by medical personnel from whom they had sought assistance (33.7%) was observed
to be the reason for women reporting for treatment with advanced disease. We observed
that 55.4% did not complete treatment. Noncompliance before the onset of and during
therapy was observed in 22.39% and 19.56% respectively. Among those who completed
treatment (44.6%), the disease status was unknown in 54%. The Internationally accepted
5 year survival rates for stages II, III and IV are 58%, 37% and 8% respectively. Thus the
results of therapy of advanced cancer cervix are far from satisfactory. Patients with
advanced and recurrent disease suffer from agonising pain, foul smelling vaginal
discharge and may develop Incontinence of urine and or faeces. Many are abandoned
by their families because of the intolerable odour. The final outcome is an undignified
death.
These observations at the Department of Gynaecologic Oncology convinced us that the
answer is prevention and early detection of cancer cervix, especially as the results of
the therapy observed internationally of preinvasive and early stage disease yield 5 year
survival rates of 100% and > 82% respectively.
Organised cytology based screening programmes have led to the control of the disease
in developed countries. However financial constraints prevent the use of such screening
programmes in this country. The World Health Organisation in 1986 suggested the
concept of downstaging cancer cervix using visual inspection of the cervix as the test
for early detectioi\.
Since 1991 the Department has been Involved in two operational field research projects
financed by the Indian Council of Medical Research and the World Health Organisation
through the Ministry of Health, Government of India, which attempted to assess whether
the staff of the health infrastructure in the areas covered by four Primary Health Centres,
could be trained to impart health education, perform visual inspection of the cervix and
triage it's appearance into normal, abnormal, and suspicious of malignancy and refer
appropriately. The target population comprised of women aged between 35 and 64
years. The results indicated that while the staff could be trained to perform the test for
early detection of cancer ce'rvlx in rural India, the task of imparting health education
and empowering women with knowledge about cancer cervix could not and should not
be their responsibility alone. Hence we looked for organisations or individuals who
could be involved In imparting health awareness. The existing Mahlla Mandals with
whom we had already attempted to work was obviously not the answer.
It is well accepted that NGDO's working in rural and semiurban areas have an integrated
approach, develop a close contact with the population and along with developmental
work many have been working in the area of health. They have experience in empowering
the population amidst whom they work. We collaborated with two such organisations.
The results indicated that in these areas the staff of the health Infrastructure were able
to cover a larger number of women when compared to the number that were covered in
the Initial study.
Thus we were convinced that the strategy could be adopted in the areas where NGDO's
work. The attention was next focussed on areas where there were no NGDO s and the
aim was to try and develop a strategy that would be successful in such areas.
About 30% of the members of the panchayat system that now exists in the country are
women. The women in these local bodies of self government if empowered with knowledge
about early detection of cancer cervix could be made responsible to ensure that the
women aged between 35 and 64 years who lived in their areas, underwent the test for
early detection.
Such women panchayat members could also help to ensure
accountability of the health infrastructure. Thus they could play the role that the NGDO's
would do in their areas. This possibility is at present being assessed in our project
areas.
Thus a phase has now been reached when an interaction with experts is imperative in
order to draw meaningful conclusions from the experiences of this study. Such an
interaction would assist in evolving the direction in which objectives of this study should
be modified in order to contribute towards the development of a pragmatic policy for the
early detection of this preventable gynaecological cancer.
SPECIFIC OBJECTIVES OF THE WORKSHOP
To create a forum where cancer specialists interact with the Panchayat System,
NGDO's (with an interest in health ), members of the Health Infrastructure,
officials of the Departments of Health and Family Welfare, Women Child and
Development and Rural Health & Panchayati Raj and policy planners in order
to share experiences and examine strategies with a view to develop a plan of
action for the control of cancer cervix and
a.
To propose that the Departments of Health and Family welfare and the
Health infrastructure, Women and Child Development, Rural Development
and Panchayati Raj of the Government of Karnataka, NGDO's especially
those with an interest in health and the Department of Gynaecologic
Oncology, Kidwai Memorial Institute of Oncology work in tandem in order
to undertake early detection of cancer cervix.
b.
To create an awareness that health workers can be technically equipped
to carry out prevention and early detection of cancer cervix.
c.
To prepare for launching an all out campaign for early detection of cancer
cervix.
PROPOSALS FOR FOLLOW-UP
The expertise of the workshop will be used to :
A.
Delineate alternate strategies and policy choices in Karnataka, India.
B.
Launch a campaign for the control of cancer cervix on a wider scale within the state
of Karnataka, in areas to be identified at the workshop in consultation with the
Departments of Health and Family Welfare, Rural Development and Panchayati Raj
and Women Child and Development Government of Karnataka and NGDO's.
C.
The proceedings of the workshop will be published as a section in the report of the
operational field research project that the department has been undertaking which
will be entitled " The Community Approach for the Control of Cervical Cancer in
India
list of participants unconfirmed
Dr. Amrit Syngle
Survival for Women & Children Foundation
Chandigarh.
Dr. R.S. Arole,
Comprehensive Rural Health Project
Jamkhed
Amal Charles
Mahbubnagar
Alice Joseph
Sumana
Mysore
Dr. Amrit Syngle
Survival for Women and ChUdren Foundation
Chandigarh
Mrs. Annie Chacko
Regional Makers Training School
Dindigal
Tamilnadu
Prof. Amitavenn
WHODSIC
Women House Holds Development
Studies Information Centre
Baroda.
St. Agnes
The Win Centre
Kerala.
Bindu M
'Sthrevedi'
Thiruvambadi,
Thirissur.
Chandrashekar
FEDVORK
Federation of District Voluntary
Organisation Kolar,
Kolar
Dr R.N. Chakrebarty,
Head Department of Preventive Oncology,
Calcutta.
Dr. Daisy Dharmaraj,
Prepare
India Rural Reconstruction &
Disaster Response Service
Bangalore(NIMHANS)
Dharesh B. Shrimali
Naturopath & Mag Theraphy
Community Health Worker
Sr. Elsey Jeeb
Nava Jyothi
Martarndam
Dr.Gurushant Limbtat
UNESCO Club
Gulbarga.
t
C.B. George,
India Development Service
Dharwad.
Dr. L.B. Gurushant
AIMS
1
Gulbarga.
Jyothi Agarwal
Karuna Trust
B.R. Hills
Mysore.
Dr. V. Janardhana Rao
R.D.T. Hospital,
Kalyandurg.
Mr. Jay Maickal
Rural Literacy & Health Programme
Mysore
Kailash Mishra
Awareness
Organisation for Promotion of
Socio-Cultural Awareness &
Preservation of Civil Democratic Morality
ORISSA.
Prof. V.R. Kushtagi
Swami Ramananda Teerth
Research Institute
Gulbarga.
Krishnaswami
170, Pramthi
Banashankari II Stage
Bangalore.
Mr. N. Madhu Sudhana Rao
Social Action for Needy People
Uppal
Andhra Pradesh
Manoj - Bodonaik
FARR, Bolangir Project
Friends Association for Rural Reconstruction
Orissa.
Mr. R.K. Mani,
SAMSKAR
Chelli Nilayam
Varni
Dr. Mira Shiva
VH AK
Bangalore.
P.R. Nawab Mani
The Agency for Rural Developmen
& Consultancy Services
Madras.
E. Narayan Reddy
CASES
Community Action for
Social Education Society
K.G.F.
Nageshwari
Women Resource Centre
Thummapala.
T. Nageshwari
Anakapalle
S.V.D.S.
Andhra Pradesh.
Neena Raina
S W A C H Foundation,
Jaipur.
Dr. Omen Abraham
Hosakote Mission & Medical Centre
Hosakote.
Dr. Patricia Bidinger
Institute for Rural Health Studies
Hyderabad.
Pragathi
Society for Rural Development
Channagiri.
Dr.V.Prakash Kotecha
Jetalpur
Baroda.
Dr. Ravi S. Kittur
Belgaum Integrated Rural
Development Society,
Naganur(Reg)
Belgaum.
Rauiachandra Pandith
Harijana Adivasi Shikshana
Prashikshana Kalyana Samstana
Bihar.
Ravindra
People's Development Centre
Bagepalli.
I
Rani
Jyothis Medical Mission
Kerala.
Mr. Srinivasa
Dhwani
’
Institute for Rural Development
Mandya.
Sunanda Rosanar,
Shree Sharada Vidyalaya
Bijapur.
Sunita Nigam
Indian Institute of
Health Management Research
Jaipur.
Dr. Sumita G. Limbitat
Sushrut Hospital & Research Centre
Afzalpur
Gulbarga.
Sr. Sally Joseph
Holy Cross Convent
Pornulur
Tamllandu.
Secretary
World Peace Public Health &
Charitable Trust
Afzalpur.
Santhamma G.S.
Santhlgrain
Pullalvila
Kerala.
M. Siddiqui
CNCI
Calcutta.
Seetha Anagol
(Co-ordlnatory Unit Bangalore)
World Conference on Women
Beijing.
Santhosh Vas
JANODAYA
Jayamahal Extension,
Bangalore.
Dr. L.P. Thangavelu
Ashwin Hospital
Coimbatore.
D. Umopani
Bapuji Integrated Rural
Development Society
Huliyur.
Veena Shatrugna
National Institute of Nutrition
Hyderabad.
Position: 1010 (5 views)