Clinical Study

Summary of Study by:

H.SONOO
T.SAI
S.MAESAKI
INTRODUCED IN SURGERY PUBLISHED IN JUNE
1992 “BREAST SELF EXAMINATION”
By: H.Sonoo, T. Sai, S. Maesak

Knowledge and Practice Ratio

According to a survey we have conducted on 1,884 mammary gland outpatients, 54.8% of them
had heard of BSE. We also asked 100 of the subjects if they knew how to practice BSE. Of
the 100 patients, 42 had some knowledge of its application. The same survey has also revealed
that only 7.9% of the subjects practice BSE on a monthly basis and that 28.4% of them on rare
occasions.

Correct Understanding
Among those who actually practice BSE, only a limited number of women perform the self
exam using the correct technique on the correct date. We must ensure that they are given correct
information on its practice method. It is also necessary to give them more opportunities for
training.

Education/Guidance
Introduction and training of BSE are being given at group health examination centers, local
community classes or hospitals mostly by nurses and in some cases by doctors. But the reality
is that the nurses who play a major role in providing BSE guidance are not always qualified or
experienced in Breast Examination. According to a survey conducted in Fukuoka City, only 25%
of the nurses feel confident in giving BSE guidance; 65% of these nurses have not even touched
cancerous tumors. This survey shows that we are lacking qualified staff for BSE training. Nurses
need to be well educated and trained for an effective penetration of BSE. Halls reports that with
an extra thirty minutes of training on BSE by using a plastic breast, he was able to increase self
examination sensitivity ratio from 25% to 50% and that pseudo-positive ratio of tumor detection
improved from 7% to 18%. It can be pointed out that if we spend longer time on each BSE, we
can expect higher sensitivity ratio.

Effects of Breast Self-Examination

The majority of breast cancers are found by the patients themselves. In most cases, they notice a
tumor or some form of irregularity on their breast and ask for a doctor’s diagnosis. According to
1984’s national survey on breast cancer patients, 92.4% of patients are reported to have detected
tumors by themselves. Another survey shows that those who practice monthly BSE are more
prompt in asking for further medical examinations when they notice the first sign of abnormality.
As this study shows, regular practice of BSE is extremely important for early detection. Ogawa’s
study in 1987 has revealed the following facts:
His report demonstrates that those who practice BSE monthly have a better chance of early
detection (1st stage cancer when the tumor is below 2 cm in diameter) than those who do not
practice BSE. Huguley, Tamburini, Feldman, Foster agree with Ogawa in reporting that small
tumors (below 2 cm diameter) are more frequently found among those who practice BSE on a
regular basis. The majority of reports present a similar result as shown by Ogawa. We can safely
conclude that BSE is an important instrument for early detection and that monthly BSE is highly
recommended.

PROLONGATION EFFECT: In his case study of 1,004 breast cancer patients, Foster has
compared the death rate and the 5 year survival ratio between those who practiced BSE and
those who did not. After observing his subjects for a period of 52 months, he reports that the
death rate
of the group that practiced BSE was 14%, while the group that did not practice BSE was 26%.
The 5 year survival ratio of the BSE group was 75%, while the latter was 59%.

Foster has concluded that BSE has an immediate effect on early detection and helps to improve
the survival ratio. Huguley has conducted a similar survey on his 2,093 breast cancer patients
and reports that the 5 year survival ratio of those who practiced BSE is higher that of those who
did not. Ogawa’s report on the death rate shows the following facts:

As stated above, we can conclude that BSE is an effective tool for early detection.

Breast Self-Examination by Vital BSE Aid: Its Effectiveness

In an attempt to evaluate the effectiveness of the Vital BSE Aid, we have studied 832 cases of
mammary gland outpatients. The following shows tumor detection ratio (i.e. touching ratio) by
Vital BSE Aid.

Breast Cancer
PATIENTS 98.6% (71/72)
NURSES 100.0% (72/72)

By using the Vital BSE Aid, nurses were able to detect 100% of the tumors. There is one case
in which a patient was unable to detect a tumor by using Vital BSE Aid. This tumor, which was
detected at group examination, had a diameter of 3.2 cm. The patient was unable to find it by
unassisted BSE, as well. This was totally due to her lack of knowledge.

Fibroma

Mastitis
NON-TUMOR (INCLUDING NORMAL BREAST, ABNORMAL NIPPLE SECRETION
AND PAIN IN MAMMARY GLAND)
PATIENTS 9.8% (45/458)
NURSES 4.8% (22/458)
There were 52 patients who detected a “lump” by regular BSE and came to us for further
examination. We had these patients try the Vital BSE Aid. The aid was able to identify 30
of the lumps (57.7%) as non-tumors. Tried by nurses, the Vital BSE Aid again identified 43
of the lumps (82.7%) as non-tumors. Among 162 cases of non-tumors, which were detected
as “tumors” by group examination, the Vital BSE Aid was able to identify 141 of them (87%)
as non-tumors. When used by nurses, the aid was again able to identify 143 of the lumps as non-
cancers. From our studies of the Vital BSE Aid, we can conclude that it is a highly effective
instrument for early breast cancer detection; as effective as palpation. Another feature is that it
is able to screen serious tumors from benign “lumps” or non-tumors, which do not require any
further examinations. The Vital BSE Aid is expected to be widely used by a large number of
medical institutions as an effective supplemental tool for self-examination. The aid can also be
used by doctors for their educational purposes.

Disclaimer: there is no guarantee that the Breast Check device will detect breast cancer. It
is not a substitute for mammogram or medical examination.
Clinical Study
Summary of Study by:
Inventive Products, Inc.
Sensor Pad Research
I. Rene Verry, Ph.D.

This experiment examined the degree of accuracy and speed in active touch lump detection using
a newly developed device called the Breast Check BSE Aid. Thirteen female subjects probed
urethane foam models containing either a lump (.13, .18, .25, .30, .43, .58mm) or no lump.
Subjects probed the models with their fingertips using the Breast Check BSE Aid on 80 trials and
their fingertips directly on the remaining 80 trials. The percent accuracy data and the reaction
time data yielded comparable results with subjects showing significantly greater accuracy and
shorter latencies on trials when the Breast Check BSE Aid was used than when it was not.

The results demonstrated that when lumps are above the subject’s absolute threshold (L3-L6),
the Breast Check BSE Aid enhanced the accuracy of lump detection. The mean catch trial scores
revealed that, overall, subjects tended to produce few false alarms. Examination of the Aid/No
Aid main effect revealed that, overall, subjects were more accurate in detecting lumps on the Aid
trials than the No Aid trials. In sum, analysis of the mean percent accuracy scores support the
interpretation that the Breast Check BSE Aid enhanced lump detection ability.
Examination of the Aid/No Aid main effect revealed that, overall, subjects had shorter latencies
on Aid than No Aid trials. Newman-Keuls posttests on the Lump Stimulus main effect showed
that reaction times were generally longer the smaller the lump. Stimulus interaction again
substantiated the conclusion that reaction time varied both as a function of lump size and Breast
Check BSE Aid Usage. Consistent with the mean percent accuracy data, the mean reaction time
data supported the interpretation that the Breast Check BSE Aid enhanced lump detection.

In conclusion, the mean percent accuracy data and the mean reaction time data supported
the predictions that the Breast Check BSE Aid enhanced active touch. Specifically, subjects
were more accurate and took less time to find the lump when the Breast Check BSE Aid was
used. Subjects typically reported, during debriefing, that the Breast Check BSE Aid seemed to
exaggerate the lumps making them “feel” larger or easier to notice.