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These results clearly show that a single-visit approach with VIA followed by
immediate treatment with cryotherapy for those testing positive (or referral
as indicated) is safe, acceptable, feasible, and with sustained effort, can
achieve moderate population coverage. The project provides important safety
information for policymakers in developing countries who are considering how
best to initiate or strengthen fledgling cervical-cancer prevention programmes.
Follow-up data indicate no clinically apparent pelvic inflammatory disease or
stenosis as a result of cryotherapy. And, the overall minor complication rate
(within a year post-treatment) associated with nurses doing cryotherapy
without colposcopy was lower than anticipated (2·2%). It is unlikely that
serious problems post-cryotherapy went unreported, because project staff
routinely investigated problems at local facilities, and all women had a card
indicating project participation.
This single-visit approach seemed to be acceptable not only to women but also
to their partners and to project providers. Results from qualitative
acceptability studies, to be published subsequently, will provide additional
insight into how acceptable the project was, and aspects in need of attention.
This Thailand experience also shows that it is logistically feasible to refill
carbon-dioxide tanks and transport cryotherapy units between sites for mobile
services. The low number of working parts that could malfunction, and training
in equipment care, contributed to the ability to maintain these units in the
field. Treatment postponements for clinic- related reasons were few,
concentrated early on when project logistics were being worked out. The
average number of women tested and safely treated daily suggests a
consistently high demand for services and an ability to safely manage the
demand. Home-care adherence and scheduled return visit rates were high. This
probably shows the quality of counselling about reasons for abstinence or
condom use, that women were offered the opportunity to postpone treatment if
needed to negotiate with their husband, and the high level of regard for the
government medical system among rural Thai women.
Costs are a large part of the effort needed to sustain a prevention programme.
Many screening and case management approaches for cervical neoplasia were
computer modelled, in the context of rural Thailand, to predict incidence and
mortality reductions and costs associated with each approach.14
Comparing each approach with no organised screening (estimated at US$2 per
woman), the most cost-effective approach was VIA, followed immediately by
cryotherapy (or referral for lesions ineligible for immediate treatment),
every 5 years for the age 35-55 year cohort. Mortality reductions over 25%
were only predicted if at least 70% of targeted women were tested each
screening cycle. In this project, coverage after 7 months was 17%. If project
efforts (including funding) were sustained, over 70% coverage in the four
districts could be achieved within 5 years. Project women, however, reported
taking on average 14·5 min to reach the facility--meaning coverage rates
reflect use of services by women living close. The effort needed to recruit
women living in more remote areas remains to be determined. The current phase
of the project focuses on this important question.
Because we aimed to test the single-visit approach as it would probably be
implemented as part of a programme, no other measure of disease status other
than VIA testing was obtained before treatment.27 Therefore, actual
treatment cure rates were not measurable. However, acetowhite lesions 1-year
post-treatment provide an indication of the need for retreatment (and/or
referral) and are something that can be feasibly monitored in regular
programmes, as part of routine quality assurance. Importantly, in this
project, the test-positive rate at 1 year was only 5·7%, with one
adenocarcinoma (of low stage). Although cryotherapy was inappropriate if the
adenocarcinoma was present but missed at initial testing, it could also be
argued that a low stage, treatable cancer was discovered as part of the
project (that would otherwise have very likely gone unreported or surfaced
only at a much later stage). Since VIA's negative predictive value (primary
testing) is consistently reported at 96% or greater,7,9,10,12 the
low project test-positive rate at 1 year should reassure policymakers that
cancers were not misdiagnosed in the first place.
It is noteworthy that for most of those treated, the squamocolumnar junction
was visible to the nurses at 1 year. A generally held opinion about
disadvantages of cryotherapy is that after treatment, the junction recedes
into the cervical canal, is no longer visible, and therefore cannot serve as a
landmark for detecting precancers. In this project, in parous women, the
junction initially seemed to be well out on the face of the exocervix, such
that even after the cervix had healed post-cryotherapy, it remained visible,
and repeat assessment by VIA was possible.
For over 30 years, Thailand has struggled to make a cervical-cancer prevention
programme based on a test-and-refer approach (cytology-based screening and
referral of positives for diagnostic testing, including biopsy, and treatment,
when indicated) work successfully. Despite efforts to develop cytological
services, national annual cytology coverage is low (5%). Also, treatment for
rural women with precancer is available only in select hospitals. Although
additional work exploring the programmatic potential of VIA combined with
cryotherapy is warranted to answer questions related to coverage, cost,
sustainability, quality assurance, and cryotherapy effectiveness in the hands
of non-physicians, these results indicate that a single-visit approach based
on VIA and cryotherapy done by rural nurses is safe, acceptable, and feasible.
Consequently, especially in view of the mounting cost-effectiveness data
supporting a single-visit approach,14,28 it should be considered an
alternative for areas in which the likelihood of successfully implementing a
more traditional approach to cancer prevention is low.
| Writing committee |
L Gaffikin, P D Blumenthal, M Emerson, K Limpaphayom |
| Project design |
P D Blumenthal, L Gaffikin, K Limpaphayom, P Lumbiganon,
P Ringers |
| Clinical training intervention |
P D Blumenthal, P Lumbiganon, S Srisupundit |
| Fieldwork |
P Lumbiganon, K Limpahayom, S Warakamin, P Ringers, R Lewis,
S Srisupundit, B Chumworathayee, S Kanavacharakul |
| Data management and analysis |
M Emerson, L Gaffikin, P Ringers, P D
Blumenthal, P Lumbiganon, K Limpaphayom |
Acknowledgments
Roi-et Province Ministry of Public Health nurses did the fieldwork under the
direct supervision of clinical supervisors from Khon Kaen University Hospital
(Bundit Chumworathayee, Sanguanchoke Luanratanakorn) and Khon Kaen Provincial
Hospital (Sumontha Prasertpan, Suwaree Paojirasinchai). Supervision of data
collection and data entry in the field was provided by Kesara Phuttong, with
assistance from Sodsuay Kanavacharakul and Rabiab Poomban-khor. We thank the
Roi-et Provincial Medical Directors, K Chaisiri and C Theerakanok for their
assistance with this project and the district hospital directors and other
facility staff who supported project implementation. Our gratitude to Khon
Kaen University for providing backup clinical support and supervision and the
Royal Thai College of Obstetricians and Gynaecologists for logistical and
advocacy assistance. We also thank the Thai Ministry of Public Health for its
support and encouragement. The village health volunteers deserve
acknowledgment for their contribution to participant education and
recruitment. We also thank the following JHPIEGO Corporation staff: Noel
McIntosh for overall programme guidance; Sarah Slade for training and clinical
input; Sapna Sharma for project coordination; Karen Mazziott for financial
assistance, Saifuddin Ahmed for help with statistical analyses; Sonia Elabd
for assisting with training materials and Mark Fritzler for equipment support.
Finally, the team owes a debt of gratitude to the women and their families who
participated in this project. This project was funded by a grant to the
JHPIEGO Corporation from the Bill and Melinda Gates Foundation through the
Alliance for Cervical Cancer Prevention and by the Ministry of Public Health
of Thailand.
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