A Quality
Study on Fibrocystic Breast Changes Operations
Rubi Ann
Claire Chan, MD*
Romano Nonato,
MD**
Gemma Uy,
MD***
Reynaldo O.
Joson, MD, MHA, MHPEd, MS Surg*,**,***
Department of
Surgery
Ospital ng Maynila Medical Center*, Manila Doctors Hospital**, Philippine General Hospital***
Reprint Request: Reynaldo O. Joson, MD,
Department of Surgery, Ospital ng Maynila Medical Center, Manila, Philippines;
Email: ommcsurgery@yahoo.com
Fibrocystic
Breast Changes
Abstract
Background:
Fibrocystic
breast changes is considered as hormonal changes or variations that strictly
speaking does not necessitate any surgical treatment. Objectives: To determine the prevalence of fibrocystic breast
changes operations in a private hospital, city government hospital, and a
university hospital and to describe an actual quality improvement program done
to reduce the prevalence of such kind of operations. Methods: Data gathering
from histopathologic reports of female patients who underwent breast mass
operations in the three selected hospitals from 2001 to mid-2003 was done to
get the prevalence rates, overall and by age group. A quality assurance program instituted in the city government
hospital was described. Results: Overall
prevalence of fibrocystic breast changes operations was 18 per cent. By age group, the overall prevalence was 12
per cent in patients 25 years old and younger. The quality improvement program
was able to reduce the prevalence of fibrocystic breast changes operations from
27 per cent in 2001 to 14 per cent by mid-2003. The prevalence rate in the age group 25 years old and younger
progressively decreased from 35 per cent in 2001 to 15 per cent in 2002 and
then to 7 per cent by mid-2003.
Strategies for improvement included awareness, willingness to improve,
training, and constant monitoring of outcome. Conclusion: An overall 20 per cent error of commission rate and a
10 per cent for patients 25 years old and younger are being recommended as
standards of quality care in patients with fibrocystic breast changes.
Key
Words: fibrocystic
breast changes, prevalence, quality improvement program
Introduction
Fibrocystic
changes of the breast is currently considered as hormonal changes or aberration
of normal development and involution, popularly known in the medical world as
ANDI, that strictly speaking does not necessitate any treatment more so
surgical treatment.
Fibrocystic
changes may at times be difficult to differentiate from breast cancer as well
as other breast disorders on clinical examination. Thus, errors of excising fibrocystic changes have occurred and
have been justified and deemed unavoidable and acceptable as an error of
commission for the purpose of catching a breast cancer.
With the
heightened awareness and fear of breast cancer and with the prevalent attitude
of “when in doubt, operate or have it removed” by both surgeons and lay people,
there is a tendency as observed by the authors for increasing number of
operations for supposed “breast mass” that will eventually turn out to be
fibrocystic changes.
How prevalent
are the operations for “breast mass” that turn out to be fibrocystic changes is
not known. There are no published data
on this prompting the authors to deduce that most likely and globally, such an
error of commission seems acceptable for purpose of detecting and treating a
breast cancer. The authors’ stand is
that errors of commission may be unavoidable but their prevalence should be
kept to a minimum or acceptable level as much as possible.
Thus, the general
objectives of this paper are to determine the prevalence of operations for
“breast mass” that eventually turned out to be fibrocystic changes and to
analyze quality care issues associated with a high prevalence, if present.
The specific
objectives consisted of the following: 1) to determine the prevalence of
operations for “breast mass” that eventually turned out to be fibrocystic
changes in a private hospital, city government hospital, and a university
hospital and 2) to describe an actual quality assurance program done to reduce
the prevalence of fibrocystic breast changes operations.
Methods
Three
hospitals, a private hospital (PH), a city government hospital (CGH) and a
university hospital (UH), were identified by convenience from which to get the
prevalence data from. The surgical pathology records of all female patients who
underwent breast mass operations from 2001 to 2002 (and to mid-2003 for the
city government hospital) were retrieved to get the prevalence data on
fibrocystic breast changes operation, overall and by age-group. Specfically, the following data were
gathered – total number of breast mass
operations, age range, number of breast mass operations by age group, and
histopathologic results by age group.
Breast mass operations included incision-biopsies, excision-biopsies,
partial, subtotal, and total mastectomies.
The age
grouping was by 10s except for 21 to 30, which was divided into 21 to 25 and 26
to 30. All patients operated on either
as in-patient or out-patient and under any kind of anesthesia were
included. Patients with a
histopathologic result showing entries of “fibroadenoma” and “fibrocystic
changes” were categorized under fibroadenoma.
Likewise, patients with a histopathologic result showing entries of
breast cancer and “fibrocystic changes” were categorized as breast cancer.
Descriptive
statistics were used to compute the prevalence rate.
In the city
government hospital, a quality improvement program on fibrocystic breast
changes operation was conducted starting 2001.
The program started with a 2001 baseline prevalence data gathered
through the histopathologic records as described above. Strategies used in reducing the prevalence
consisted of creating awareness of the non-necessity of the operations on
fibrocystic changes and the need to have a acceptable error of commission,
followed by training of the surgical residents on how to recognize the
condition and what to do to minimize error of commission, and regular
monitoring and feedback. The prevalence
in the subsequent years was compared with the baseline data. All the above data were gotten through
review of records of the Department of Surgery and from the Department of
Pathology.
The overall
prevalence of fibrocystic breast changes operations in the three selected
hospitals was 18 per cent (Table 1).
The hospital prevalence rate was 30 per cent for PH, 22 per cent for
CGH, and 15 per cent for UH. (Note: CGH
had undergone a formal quality improvement program in 2002 while the other two
hospitals did not.)
By age group,
the overall prevalence of fibrocystic breast changes operation was 12 per cent
in patients 25 years old and younger; 24 per cent in those between 26 to 30
years old; and 15 per cent in those above 30 years old (Tables 2 and 3).
Prior to the
quality improvement program in CGH, the baseline overall prevalence rate of
fibrocystic breast changes operation was 27 per cent (Table 4). The prevalence rate was reduced to 19 per
cent in 2002 and to 14 per cent by mid-2003.
The prevalence rate in the age group 25 years old and younger
progressively decreased from 35 per cent in 2001 to 15 per cent in 2002 and
then to 7 per cent by mid-2003.
The quality improvement
program started in 2001 with a situational analysis of the perceived problem of
high prevalence of unnecessary fibrocystic breast changes operations. A baseline prevalence was gotten, both
overall and by age group. The consensus of the staff then was that the
prevalence was unusually high in patients 25 years old and younger. A resolution was made to reduce it
particularly in this age group through training of the surgical residents on
how to recognize fibrocystic changes clinically and how to minimize errors of
commission. For the latter, a protocol
was formulated consisting of active and regular monitoring of patients with
primary diagnosis of fibrocystic breast changes, using needle evaluation as a
paraclinical diagnostic procedure as much as possible, and referral to a more
senior resident for second opinion as necessary. A regular and constant monitoring system was established
consisting of a report card individually and regularly accomplished by the
residents on the prevalence of their fibrocystic breast changes operations as
well as a departmental tissue review every six months.
Discussion
Fibrocystic changes represent an
exaggerated physiologic response to a changing hormonal environment and include
painful breasts (mastodynia), and lumpy breasts (presence of focal or diffuse
irregular thickening). Fibrocystic
changes also represent normal developmental changes
in the breast can lead to harmless aberrations, the basis for the term ANDI
which stands for “aberration of normal development and involution.”
Most women experience fibrocystic
changes and for this reason, they are considered normal. Thus, to label this
condition a disease is inappropriate.
There was a question before
whether fibrocystic changes is a precancerous condition. The consensus nowadays is that there is no
correlation between fibrocystic changes (like
proliferative changes, ductal and lobular hyperplasia) and breast cancer (1,2),
although there are some variations in the fibrocystic changes that create a
predisposition to breast cancer. These,
however, are rare (3-5) In a study by Love, in 6,500 women with
fibrocystic breasts, only 3 per cent went on to have breast cancer (6).
Thus, with fibrocystic changes
being a normal condition and with no correlation to breast cancer, operations
on such condition are strictly speaking considered unnecessary. It there are errors of commission committed,
these are due either to error in preoperative diagnosis or to a fear of missing
a breast cancer, in other words, committing an error of omission.
In the practice of medicine,
physicians should always balance errors of commission with errors of
omission. Excess in either type is a
sign a poor quality patient care.
In fibrocystic breast changes,
what is considered an acceptable error of commission or put it in other way,
what is an acceptable error of omission for breast cancer is not known as there
are no data on these issues in the literature.
In the absence of standards to go
by, the authors decided to rationalize a standard through this study.
In an internet publication of
Memorial Sloan-Kettering Cancer Cetner (7), the risk of developing breast
cancer by age is listed in Table 6.
From this table, one can see that
the chances of developing breast cancer increase with age. A woman in her 20s has the least chance of
developing breast cancer compared to an older woman. Thus, if a list of acceptable error of commission for fibrocystic
breast cancer will be put up, the percentages should be directly proportional
to the increasing age. Younger patients
should have lower percentages while older patients, higher. Those 25 years old
and younger should have the smallest acceptable error of commission rate. However, exactly, what percentages these
will be for each group, at the moment, there are no data-driven figures.
This paper can be considered as a
pilot project to get data-driven standards for accepted error of commission for
fibrocystic breast conditions. The
prevalence data from the three selected hospitals could be used as the starting
point from which to get the standards.
The selected hospitals used in this study seemed appropriate in
representing three settings in the country where error rates of commission can
vary.
Based on the data in Table 1 and
Table 3, the authors suggest using 20 per cent as the overall acceptable error
of commission rate and 10 per cent as the acceptable error of commission rate
for patients 25 years old and younger.
As to error of omission rate, the authors were not able to work on this
as the consensus was that it would be extremely difficult, if not impossible,
to work on. Follow-up and long term at
that is needed. The authors suggest
that at the moment, the usual 10 per cent false-negative rate of mammography be
adopted for the acceptable error of omission in patients diagnosed to have
fibrocystic breast changes.
The quality improvement program
conducted in the city government hospital illustrated that reduction of
prevalence of unnecessary fibrocystic breast changes operation can be
done. The strategies are simple, which
consisted of initially creating awareness of the issue, then committing to
improve the quality of care in such patients, and then implementing the
specific improvement measures of training the surgical residents on how to
recognize the condition and what to do to minimize error of commission through
active and regular monitoring with or without the use of needle evaluation and
other ancillary diagnostic procedures,
training and lastly, constantly
and regularly evaluating and monitoring the results, such as on a bi-annual or
annual frequency.
References
1.
Sinclair RA. The breast: tissue changes and cancer risk. Med
J Aust. 1988;149(8):424-6.
2.
Prognostic significance of benign proliferative breast
disease. Cancer. 1993; 71(12):3896-907.
3.
Bodian CA, Perzin KH, Lattes R, Hoffmann P, Abernathy TG. De
Leon Antoni E. Is fibrocystic disease
precancerous? Bol Asoc Med P R. 1989;81(11):451-4.
4.
Haagensen DE Jr. Is cystic disease related to breast cancer?
Am J Surg Pathol. 1991;15(7):687-94.
5.
Sarnelli R, Squartini F. Fibrocystic condition and "at
risk" lesions in asymptomatic breasts: a morphologic study of
postmenopausal women. Clin Exp Obstet Gynecol. 1991;18(4):271-9.
6.
Love SA. Dr. Susan Love’s Breast Book, 3rd ed. Addison-Wesley, 2000.
7.
http://www.mskcc.org/patient_education/html/7108.cfm
Table 1. Prevalence of fibrocystic
breast changes operations in the three selected hospitals, from 2001 to
mid–2003.
|
PH
(2001-2002) |
CGH (2001-mid2003) |
UH (2001-2002) |
Total |
Total breast mass operations |
802 |
386 |
3560 |
4748 |
No. of fibrocystic change histopath
diagnosis |
243 |
85 |
524 |
852 |
Prevalence |
30% |
22% |
15% |
18% |
Table 2. Prevalence of fibrocystic
breast changes operations by age group in the three selected hospitals from
2001 to mid-2003.
|
PH
(2001-2002) (n=243) |
CGH (2001-mid2003) (n=85) |
UH (2001-2002) (n=524) |
Total (n=852) |
1-25 |
23 (20%) |
49 (23%) |
100 (9%) |
172 (12%) |
26-30 |
67 (33%) |
18 (18%) |
84(21%) |
169 (24%) |
31-40 |
84 (35%) |
14 (25%) |
124 (18%) |
222 (23%) |
41-50 |
50 (35%) |
4 (20%) |
158 (20%) |
212 (25%) |
51-60 |
14 (19%) |
0 |
43(12%) |
57 (13%) |
61-70 |
3 (20%) |
0 |
12 (6%) |
15 (7%) |
>71 |
2 (28%) |
0 |
3 (6%) |
5 (4%) |
** (%) = number of fibrocystic changes
/ number of patients who had breast mass operations in the specified age group
x 100
Table 3. Prevalence of fibrocystic breast changes operation by age group
in the three selected hospitals from 2001 to mid-2003 using three categories of
age group.
|
PH
(2001-2002) (n=243) |
CGH (2001-mid2003) (n=85) |
UH (2001-2002) (n=524) |
Total (n=852) |
25 and younger |
23 (20%) |
49 (23%) |
100 (9%) |
172 (12%) |
26-30 |
67 (33%) |
18 (18%) |
84(21%) |
169 (24%) |
Above 30 |
153(22%) |
18 (23%) |
340 (17%) |
511 (23%) |
** (%) = number of fibrocystic changes
/ number of patients who had breast mass operations in the specified age group
x 100
Table 4. Prevalence of fibrocystic breast changes operations in CGH, 2001
to mid-2003.
|
2001 |
2002 |
mid-2003 |
Total |
Total breast mass operations |
180 |
134 |
72 |
386 |
No. of fibrocystic change histopath
diagnosis |
49 |
26 |
10 |
85 |
Prevalence |
27% |
19% |
14% |
22% |
Table 5. Prevalence of fibrocystic
breast changes operations by age group in CGH from 2001 to mid-2003.
|
2001 (n=49) |
2002 (n=26) |
mid-2003 (n=10) |
Total |
|
|
|
|
|
1-25 |
35 (35%) |
11 (15%) |
3 (7%) |
49 (23%) |
26-30 |
10 (20%) |
5 (19%) |
3 (14%) |
18 (18%) |
31-40 |
2 (8%) |
8 (35%) |
4 (40%) |
14 (30%) |
41-50 |
2 (33%) |
2 (22%) |
0 (0%) |
4 (25%) |
51-60 |
0 |
0 |
0 |
|
61-70 |
0 |
0 |
0 |
|
>71 |
0 |
0 |
0 |
|
** (%) = number of fibrocystic changes
/ number of patients who had breast mass operations in the specified age group
x 100
Table 6. Risk of developing breast
cancer by age, MSKCC.
Age |
Risk |
Age 25 |
1 in 19,608 |
Age 30 |
1 in 2525 |
Age 35 |
1 in 622 |
Age 40 |
1 in 217 |
Age 45 |
1 in 93 |
Age 50 |
1 in 50 |
Age 55 |
1 in 33 |
Age 60 |
1 in 24 |
Age 65 |
1 in 17 |
Age 70 |
1 in 14 |
Age 75 |
1 in 11 |
Age 80 |
1 in 10 |
Age 85 |
1 in 9 |
Ever |
1 in 8 |