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51
Design and Conduct of a LowCost Mammography Screening Project: Experience of the American Cancer
Victor G. Vogel1 George N. Peters2 W. Phil Evans2 Texas Breast Screening Project, Scientific Review Committee3
To
improve
Received April 11 , 1991 ; accepted
after revision
1991.
This work was supported
by grants from the
American Cancer Society, Texas Division, Inc., the Texas Cancer Council, the Susan G. Komen Foundation (Dallas), and the Kelsey-Seybold Foundation (Houston). V. G. Vogel is a recipient of an American Cancer Society Career Development Award. , University of Texas, M. 0. Anderson Cancer Center, 1 51 5 Hobcombe Blvd., Houston, TX 77030. Address reprint requests to V. G. Vogel. 2
Baylor
University
St., Dallas,
Medical
Center,
3409
Worth
TX 75246.
Members: George N. Peters, Chairman; Ardow John J. Costanzi; Gerald D. Dodd: Phil Evans Ill; Gilchrist Jackson; Ray 0. Lundy; John C. 3
Ameduri;
O’Brien, Jr.; C. Kent Osborne; Charles Oswalt; Daniel Savino; Edwin D. Savlov; Victor G. Vogel, Principal
Investigator;
Rodger
J. Winn.
0361-803x/92/1 581-0051 © American Roentgen Ray Society
compliance
Texas
with
Division
recommendations
for
screening
mammography,
the
American Cancer Society (ACS) Texas Division designed and conducted a mediapromoted screening project in 1987. The project was planned during a 2-year period by a task force made up of physicians and lay members of ACS division committees. Radiology centers desiring to participate in the project were asked to submit information about the number of patients they could screen and their equipment, along with physics data, to a review committee. Of 306 facilities that responded, 266 (87%) passed the initial review. Thirteen facilities (4%) submitted images from two examinations using a dedicated mammography phantom, and 27 sites (9%) entered the project by agreeing to adhere to the project standards and guidelines without undergoing formal review. All facilities agreed to provide mammograms for $50 to women scheduling appointments during a 2-week media campaign in February 1987. The project generated 64,459 mammographic screening examinations. Our experience indicates that a media campaign can encourage women to have screening mammograms and that screening facilities will agree to screen a large number of women at reduced cost. This strategy, if widely applied, can improve compliance with mammographic screening recommendations and reduce breast cancer mortality. AJR
August2,
Society,
158:51-54,
January
1992
The number of new cases of breast cancer and the number of deaths from breast cancer continue to increase each year. In 1 990, breast cancer accounted for 29% of cancers in women and for 1 8% of cancer deaths among women [1]. Although mammographic screening reduces mortality from breast cancer [2-10], both physicians and patients express concerns about the cost of screening mammography [1 1 ]. Consequently, women are not being screened as recommended by published guidelines [12]. One method to improve use of mammographic screening is to reduce charges and simultaneously to promote the availability of mammographic screening through use of the media. In 1 987, the Texas Division of the American Cancer Society (ACS) initiated a campaign to offer low-cost mammograms to all women in the state who were age 35 or older. Before the project, it was not clear whether such a plan could be successful. The planners did not know whether the 300 mammography facilities required would agree to participate, whether the media campaign would be successful, or whether the centers would be able or willing to meet the increased demand. We describe the planning, design, and execution of the ACS 1 987 Texas Breast Screening
Project
(TBSP),
the methods
used
to evaluate
the
characteristics
of the
participating radiology centers, and the reporting requirements for abnormal findings on mammograms. We present TBSP as a successful model for populationbased recruitment to mammographic screening that can be applied in other settings. Results of the 64,459 screening examinations will be published separately (Peters GN, Vogel VG, Evans WP, Bondy M, Halabi 5, Lord J, Laville EA, unpublished
52
VOGEL
data; Vogel unpublished
VG, Bondy data).
M,
Halabi
5,
Lord
J, Laville
EA,
ET AL.
AJR:158,
producing
dose
a two-view
of less than
mammographic of $50;
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Methods Background
and
Objectives
The major aims of the project were to educate benefits
and
community
safety
of screening
health professionals
women
mammography
and
about the
were targeted in an attempt to screen asymptomatic
women. The primary objective was to increase the use of mammography for the early detection of breast cancer. The entire state was targeted, and a systematic, prospective follow-up analysis was implemented at the outset of the design phase.
Project
Design
From July 1985 through composed of representatives met quarterly. Representation,
March 1987, a Division Task Force from ACS Texas Division committees cooperation, and endorsement were
enlisted from the Texas Radiological Society, the Texas Academy of Family Physicians, the North and South Chapters of the American
College
of Surgeons,
and the Texas
Society
of Obstetrics
and
Gynecology.
from the state’s major women’s
invited
a briefing
to attend
Because Information
on the
organizations
were
project.
television participation Committee organized
was
a meeting
the
with
ACS
Public
representatives
from stations in the state’s major television markets. Participating stations agreed to conduct a 1 -week Breast Awareness Program focusing on the importance of mammography, breast self-examination, and a physical examination performed by a physician. They also agreed to coordinate these programs with ACS telephone banks in
each viewing markets
area. Co-sponsoring
also participated.
television
This effort
one tenth of the United States’
targeted
television
stations
in 20 state
17 million
viewing
viewers,
or
population.
All
television broadcasts on the benefits of mammography were scheduled for the last week of February or the first week of March 1987. A media kick-off involving radio, television, and print media was organized
at the Texas
Telephone
banks, ACS areas, required
State
Capitol
building
in early
February.
organized in the major cities of the state’s six 5000 volunteers for staffing daily from 9 am. to
midnight during the 1-week television campaign. During the campaign 109,339 women called for information; 64,459 women completed mammographic
screening
at the facility
women
were referred
to their physicians
Service
for diagnostic
evaluation.
months for completion
of their choice.
in some centers.
in 1 987
as long
as 4
Any woman who scheduled
screening during the media campaign was assured mammogram for $50. The median price for screening in Texas
Symptomatic
required
of obtaining mammography
Center
mammography
was $125.
and
(dedicated
dose in rads/exposure per
ologists
By
(5) Provide the ACS with a summary
or general
method
and
at the facility
purpose)
manufacturer,
frequency
performing
and
their specific
type of training;
examination;
additional
The two
surveys
panels,
model,
of X-ray
number
dose
measure-
interpreting
availability
breast
mammography
of training
imaging
were
one
returned
composed
techniques
information
was
to
the
area
of physicists
used;
complete
offices
and
and
to
patients;
reviewed
other
project
self-
ability
many and
the
met
and
in breast
by
of physicians. standards,
the
surveys were forwarded to the Division office in Austin for final review by the ACS Mammography Review Committee, which is composed of radiologists and physicists. Incomplete surveys were returned to the facilities for more information. After
the
if they
Division
met
the
reviewed
standards
was recommended the
ACS
final using
the
a dedicated
submit
mammography
facilities
were
A two-view
three
Committee
equipment
facilities
the
that used
Review
about the
surveys,
participation.
for facilities
determination that
the for
Mammography
requested
views
was that
images phantom.
notified
examination
per breast.
unable
to
the
facilities
used,
from
two
examinations
Facilities
that
If
make
a
they
were
not
enrolled via these procedures were given the opportunity to participate only ifthey would certify in writing that the facility would produce a two-view mammogram with an average mid-breast dose of less than
one
gists
rad
per
specifically
examination trained
in
and
employ
the
production
technologists and
and
radiolo-
of
interpretation
A total of 306 facilities agreed to participate: 266 (87%) joined the project after completion of the initial survey, 1 3 (4%) after phantom review, and 27 (9%) by strictly agreeing to adhere to the project standards and guidelines without undergoing formal reviews. The after
to
allow
much
centers
discussion.
legal reasons,
their
centers.
who
ment (thermolucent dosimetry, physicist, other); date of last dose measurement; measurement of radiation doses, entrance exposure in roentgens, beam quality (half value layer in millimeters of aluminum), target type, tube potentials (in kVp and mAs), type of compression device; current storage of mammographic records, number of radi-
exceed
mammography
cost
radiologists
to the center of the average breast;
breast;
September
1986, these facilities had been contacted and invited to participate in the 1987 TBSP, provided that they could meet the following requirements: (1) Possess dedicated mammography equipment capable of
center
to The
agreed
primary
physicians. the
center
without
to deny project
to
provide If a
reports
was
at
body. a cost
to the participants
participant
did
referral
not
for
by a facility,
certifying
a physician
made
Committee,
participation
mammograms
follow-up
provided
review
Review
was not a recognized
$50 and to provide
physician,
participate Mammography
did not want
because the committee
Recruitment
offices,
a maximum
year purchased, focal-spot size, type of breast imaging system (film, film-screen, electron radiography, or xeroradiography) grid, absorbed
decision
a
During July and August 1 986, the ACS Breast Cancer Awareness Task Force in each area office began identifying local hospitals, radiologists’
for and
report of examination results. If facilities wished to participate, they were asked to complete a four-page questionnaire requesting information about the facility: number of women examined per day; type of equipment used for
Each Screening
interpretation
of technologists
mid-breast
the two-view
mammograms.
or the Cancer Information
Screening
total
(2) Offer
1992
have been specifically trained in the production and interpretation of mammograms; (4) Accept women referred by the ACS after the media promotion and schedule them within a 2-month period (the low-cost screening offer would be only for those women who re-
If the
essential,
and
the services
an average
examined;
increase number of patients examined and by how and the contact person responsible for the project.
Beginning in the fall of 1986, articles explaining the project were placed in numerous lay and professional magazines and journals.
Representatives
examination
(3) Employ
of views The Statewide
with
sponded to the ACS promotion);
to educate
about the benefits of early detection
of breast cancer. Primary care physicians to increase their use of mammography
mammogram
1 rad per breast
January
have list.
not
to
and
a private Each
center
also provided instructions or materials on breast self-examination and agreed to schedule mammogram appointments for at least 2 months and to distribute an epidemiology survey. A radiologist and an administrator from each facility were required to attend an Area Feasibility Liaison meeting in January or February 1 987, at which the project
LOW-COST
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AJR:158, January 1992
MAMMOGRAPHY
SCREENING
PROJECT
53
overview, operation, and facility responsibilities were discussed. Representatives from each facility were asked to estimate the number of
and only
low-cost
Both physicians and patients express concerns about the cost of screening mammography. Cost is among the most frequently cited reasons for not complying with mammography screening guidelines. Awareness is growing among radi-
mammograms
they
could
provide
and
to agree
in writing
to
provide low-dose mammography (less than one rad per two-view examination), mammograms for no more than $50, physicians willing to see new patients, the ACS Patient Information Agreement signed before the patient’s examination, a final report to ACS (number of women screened), copies of all positive reports to ACS, screening appointments for a period of 2 months (to those women participating in the ACS promotion), and breast self-examination instructions and physical examinations. The ACS Patient Information Agreement Form emphasized that although mammography was the most reliable method of detecting breast cancer, it was only part of the screening process. It explained that cancers not detectable on mammography could be detected during a physician’s physical examination or breast self-examination. The form also discussed breast discomfort, the cost of the mammogram, breast symptoms, and the necessity of further evaluation if the mammographic
findings
were
abnormal.
All
participants
signed
the
form before their mammographic screening and were given a copy. The radiologists were asked to classify their reports as negative (no evidence of malignancy), indeterminate (further evaluation needed to clarify a possible abnormality), or positive (possible cancer, biopsy recommended). Sample letters that were sent to patients and physicians for examinations with either normal or abnormal findings, mammography coupons, and other project information were distributed to the facilities. The facilities were encouraged to notify women with positive mammographic findings by certified mail. Finally, on completion of the screening, the facilities were asked to submit a report specifying the total number of mammographic examinations performed; number of negative, indeterminate, and positive reports; disposition of patients with indeterminate or positive reports; number of carcinomas found, their size, the patient’s age, and nodal status. These data will be reported in other publications (Peters GN, Vogel VG, Evans WP, Bondy M, Halabi 5, Lord J, Laville EA, unpublished data; Vogel VG, Bondy M, Halabi 5, Lord J, Laville EA, unpublished
data).
The hospitals, radiologists, offices, and mammography agreeing to these requirements were listed as participating in the appropriate ACS and media publicity.
centers facilities
Discussion The ACS examination,
guidelines for physical examination, breast selfand mammography offer the potential of finding
early breast cancers with a high cure The study by the Health Insurance
rate. Plan
of Greater New York and the Breast Cancer Detection Demonstration Project both showed mammography’s usefulness for early detection of breast cancer [2-4]. Controlled trials in Sweden [5, 6], the United Kingdom [71, the Netherlands [8, 9], and Italy [10] have shown a 2O% or greater reduction in breast cancer mortality
rates
among
screened
women.
Despite
these
en-
couraging findings, in 1 985 only 1 1 % of primary care physicians followed the ACS guidelines for screening mammography. Major reasons for physicians’ disagreement with the
ACS guidelines included high cost of mammography
(reported
by 39% of the physicians), lack of necessity when women are asymptomatic (29%), radiation exposure (25%), and low yield (1 6%) [1 1]. In 1 986, only 5% of women more than 50 years old in the United States were having annual mammography,
one third
mammogram
ologists
of the eligible
women
ever
had a single
[12].
that
efforts
to reduce
the cost
of screening
mammog-
raphy are necessary if compliance with screening recommendations is to be achieved [13]. A number of investigators have shown that screening mammography can be done in high volume and at lower cost than diagnostic mammography. It requires qualified radiologists and technologists, a high daily volume of patients, low overhead,
and
a reduction
in time
spent
by
radiologists
in
reviewing films daily [1 4]. The mechanisms for initiating a lowcost screening center have been described [1 5, 16], and the ability of low-cost centers to provide acceptable results has been well documented [1 7, 18]. Few efforts have been made to provide low-cost screening mammography to entire populations. Population-based screening requires the participation of a large number of screening facilities. This raises concerns about radiation exposure,
image
quality,
and
film
interpretation.
The
American
College of Radiology has developed a mammography accreditation procedure to facilitate production of optimal-quality mammograms with a high breast cancer detection rate [19]. This procedure includes a comprehensive questionnaire that establishes personnel qualifications and determines equipment specifications, quality assurance procedures, radiation dosages, and follow-up procedures. The evaluation process used in this project was not as rigorous accreditation.
as that
of the
Even
ACR,
though
nor did it provide the
task
force
certification
included
or
a Radiol-
ogy Review Committee, it was thought to be inappropriate for this planning body to offer certification. It was also the sense of the committee that, although it could make recommendations and request additional data from prospective participants, it could not refuse to allow any facility to join the project. Only 27 (9%) of 306 facilities entered the project without undergoing formal review. That is, they did not meet all the suggested guidelines for participation. We do not have data on the performance of radiology facilities that did not participate in the project, but it is possible that the project evaluation process discouraged less-capable facilities from applying for participation. Radiologists from the screening centers that participated in TBSP had few complaints about the design of the project. Some centers faced scheduling difficulties in accommodating the increased demand, and scheduled screening as late as 3 months after the media campaign. After the project, staff at these centers requested that future projects contain limited registration
periods
(e.g.,
2 weeks)
during
which
appoint-
ments could be scheduled at reduced cost. Some centers also felt that the reporting requirements and paperwork required for the American Cancer Society division office were burdensome. Future projects should attempt to keep the added reporting requirements to a minimum if media campaigns are to be repeated regularly. Although we have follow-up data on a large proportion of
VOGEL
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54
the women with positive findings on mammograms from this project, we do not have information about the number or proportion of examinations that were false-negative. We did not have adequate resources to follow up the women with negative mammographic reports. Future population-based programs should attempt to implement methods to determine the false-negative rate. This may be possible in states with cancer incidence registries, but it will be difficult or impossible where registries do not exist. Future projects should use only two interpretations for mammograms,
normal
(negative)
or abnormal
(positive).
among projects conducted where specific management
in of
women with abnormal mammograms may differ. In TBSP, some participating centers interpreted the indeterminate category as including women who required additional views on subsequent mammograms, those who needed comparison of
TBSP films with prior mammograms, and those women who had sonographic examinations. Other TBSP centers reported these women in the positive category. The two-category classification system avoids the ambivalence of an indeterminate category in which there is great heterogeneity of the mammographic abnormalities that complicates comparisons of both screening outcomes and costs. Follow-up of population-based campaigns is essential to the evaluation of their effectiveness. The most convincing information to indicate screening efficacy is improvement in survival, and we do not yet have that data for TBSP. Time and cost considerations make it difficult to gather such information. In the absence of survival data, all population-based screening programs should collect data about the numbers of biopsies performed, the benign-to-malignant biopsy ratio, and the stage of the cancers detected. Data should be collected from participants and nonparticipants to determine the reasons for their participation status. Population-based mammography screening programs are effective mechanisms for increasing compliance with screening mammography recommendations [20-22]. Adequate follow-up mechanisms should be included in the design of these projects so that their success can be adequately demonstrated.
1 . Silverberg E, Boring CC, Squires 1990;40:9-26 2. Shapiro 5, Venet W, Strax P, Venet effect of screening 1982;69:349-355
3. Baker 4.
5.
6.
7.
8.
9.
10.
11. 12. 13. 1 4.
1 5. 16.
1 7. 1 8.
attention
is directed
to the commentary
breast
Cancer
L, Roeser
cancer
Detection
Cancer
statistics, A. Ten-
mortality.
CA
to fourteen-year
J NatI
Demonstration
1 990.
Cancer
Project:
Inst
Five-year
A, Pisano
ED. Issues
in mammography.
Cancer
1990:66:1341-
1344 20. Kaufman
.
ACKNOWLEDGMENTS
The reader’s
LH. Breast
on
TS.
summary report. CA 1982:32:194-225 Chu KC, Smart CA, Tarone RE. Analysis of breast cancer mortality and stage distribution by age for the Health Insurance Plan clinical trial. J Nat! Cancer Inst 1988;80: 1125-1132 Tabar L, Faberberg G, Day NE, Holmberg L. What is the optimum interval between mammographic screening examination? An analysis based on the latest results of the Swedish two-county breast cancer screening trial. Br J Cancer 1987;55:547-551 Andersson I, Aspergren K, Janzon L, et al. Mammographic screening and mortality from breast cancer: the Malmo mammographic screening trial. BMJ 1988;297:944-948 UK Trial of Early Detection of Breast Cancer Group. First results on mortality reduction in the UK trial of early detection of breast cancer. Lancet 1988;2(8608):41 1-416 Verbeek ALM, Hendricks JHCL, Holland A, Mravunac M, Sturmans F, Day NE. Reduction of breast cancer mortality through mass screening with modern mammography. Lancet 1984;1(8388): 1222-1224 Collette JH, Day NE, Rombach JJ, de Waard F. Evaluation of screening for breast cancer in a non-randomized study (the DOM project) by means of a case-control study. Lancet 1984;1(8388): 1224-1226 Palli D, Del Turco MA, Buiatti E, et al. A case-control study of the efficacy of a non-randomized breast cancer screening program in Florence (Italy). IntJ Cancer 1986;38:501-504 The American Cancer Society. Survey of physicians’ attitudes and practices in early cancer detection. CA 1985;35: 197-213 Hall FM. Screening mammography: potential problems on the horizon. N EngI J Med 1986:414:53-55 Dodd GD. Cost reduction in mammography. Cancer 1989;64[supplj: 2667-2670 McLelland A. Low-cost mass screening with mammography as a means of reducing overall mortality from breast cancer. Radiol Clin North Am 1987;25: 1007-1 013 Bird RE, McLelland A. How to initiate and operate a low-cost screening mammography center. Radiology 1986;161 :43-47 Sickles EA, Weber WN, Galvin HB, Ominsky SH, Sollitto AA. Mammographic screening: how to operate successfully at low cost. Radiology 1986;160:95-97 Bird RE. Low-cost screening mammography: report on finances and review of 21 716 consecutive cases. Radiology 1989;171 :87-90 US General Accounting Office, Human Resources Division. Screening mammography in low-cost services do not compromise quality. Washington, DC: 1990 US General Accounting Office, Publication No. GAO/HAD90-32 McLelland
19.
21
The many and tireless contributions of Mike Dany, Vice-President for Program, ACS Texas Division, Inc., are gratefully acknowledged.
AJR:158, January 1992
REFERENCES
This
classification scheme allows assessment of the work load and resultant costs associated with a project in that only those women with positive reports require additional investigations and procedures. Positive vs negative classification
also permits comparisons various screening locations
ET AL.
22.
AJ, Worrell J, Bain AS, Jones HW, Winfield AC. American Cancer Society’s Breast Cancer Detection Awareness Program: The 1 988 middle Tennessee experience. South Med J 1990:83:618-621 Sobel J, Gordon D, Knstal A, Eklund GW, Curtin A, Kennedy P. The Oregon Breast Cancer Detection Awareness Project: Follow-up of a community-based breast cancer screening campaign. Prog Clin Biol Res 1989:293:75-87 Fink DJ. Community programs: breast cancer detection awareness. Cancer 1989;64[suppl]:2674-2681
on this article,
which
appears
on the following
pages.