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

For the prevalence data

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.

    

For the quality assurance program

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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Results

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