i i cs health care guideline: diagnosis of breast disease · 2012-10-28 · health care guideline:...

Health Care Guideline:

Diagnosis of Breast Disease

Twelfth Edition January 2008

I ICSI NSTITUTE FOR C LINICAL S YSTEMS I MPROVEMENT

The information contained in this ICSI Health Care Guideline is intended primarily for health profes-sionals and the following expert audiences:

• physicians, nurses, and other health care professional and provider organizations;

• health plans, health systems, health care organizations, hospitals and integrated health care delivery systems;

• medical specialty and professional societies;

• researchers;

• federal, state and local government health care policy makers and specialists; and

• employee benefit managers.

This ICSI Health Care Guideline should not be construed as medical advice or medical opinion related to any specific facts or circumstances. If you are not one of the expert audiences listed above you are urged to consult a health care professional regarding your own situation and any specific medical questions you may have. In addition, you should seek assistance from a health care professional in interpreting this ICSI Health Care Guideline and applying it in your individual case.

This ICSI Health Care Guideline is designed to assist clinicians by providing an analytical framework for the evaluation and treatment of patients, and is not intended either to replace a clinician's judgment or to establish a protocol for all patients with a particular condition. An ICSI Health Care Guideline rarely will establish the only approach to a problem.

Copies of this ICSI Health Care Guideline may be distributed by any organization to the organization's employees but, except as provided below, may not be distributed outside of the organization without the prior written consent of the Institute for Clinical Systems Improvement, Inc. If the organization is a legally constituted medical group, the ICSI Health Care Guideline may be used by the medical group in any of the following ways:

• copies may be provided to anyone involved in the medical group's process for developing and implementing clinical guidelines;

• the ICSI Health Care Guideline may be adopted or adapted for use within the medical group only, provided that ICSI receives appropriate attribution on all written or electronic documents; and

• copies may be provided to patients and the clinicians who manage their care, if the ICSI Health Care Guideline is incorporated into the medical group's clinical guideline program.

Health Care Guideline:

Diagnosis of Breast DiseaseI ICSI NSTITUTE FOR C LINICAL S YSTEMS I MPROVEMENT

A = Annotation

Evaluation by Primary Care of Patient with Symptoms of Potential Breast Disease

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Copyright © 2008 by Institute for Clinical Systems Improvement 1

Twelfth Edition January 2008

Perform history andphysical exam for breast-

related symptomsA

Does patienthave a palpable

mass?

Does patient havespontaneous nipple

discharge?

See Algorithm I,"Evaluation of Breast

Mass"

yes

See Algorithm II,"Evaluation of the Breastfor Spontaneous Nipple

Discharge"

no

yes

Does patienthave breast

pain?

See Algorithm III,"Evaluation of Breast

Pain"

yes

no

no

Patient is seen byprimary care physician

because of a breastdisease concern

Is screeningmammogram

due?

A

Screeningmammogram

yes

Abnormalmammogram?

Complete all radiologicrecommendations

yes Inform patient of nextscreening date

no

no

1

2

3

4

5

6

78

9

10

11

12

A

13

A

A

Institute for Clinical Systems Improvement

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I. Evaluation of Breast Mass

Diagnosis of Breast Disease Twelfth Edition/January 2008

A = Annotation

Patient presents withpalpable breast mass

Indeterminant ordominant mass?

A

Perform ultrasoundand/or diagnostic

mammogram

no

Breast imagingabnormal?

yes

Perform ultrasoundand/or diagnostic

mammogram

yes

A

Pure cyst

Follow-up clinical breastexam in 4-6 weeks atdiscretion of clinician

noResidual mass?

A

Refer to radiology orsurgery

yes

Inform patient ofnext screening date

A

no

14

15

16 18

Negative imaging

17

Solid lesion orcomplex cyst

19

Refer to surgeon

20

Consider aspiration ifsymptomatic or refer to

the appropriateconsultant

21

A

See Algorithm V,"Image-Directed Core

Needle Biopsy"

22

Residual mass orbloody aspirate?

23

A

yes

no

25

26

27

28

29

30

Refer to Algorithm IV,"Radiologic Evaluation

of the Breast"

31

Follow-up clinical breastexam in 4-6 weeks atdiscretion of clinician

24

A


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II. Evaluation of the Breast for Spontaneous Nipple Discharge


A = AnnotationPatient presents withspontaneous nipple

dischargeA

Complete all radiologicrecommendations

A

Clear or bloodydischarge

Milky, yellow,brown, green, gray

dischargeAA

Refer to surgeon(+/- ductography)

A Milky Colored

Hormonalevaluation

A

Observe/reassurepatient

Follow-up visit scheduled atthe discretion of the treating

clinicianA

Is mammogram/ultrasound normal?

no

yes

Perform mammogram/ultrasound

Refer to surgery ifappropriate

32

33

34

35 36

38 40

39

41 42

43 44

45

A

Assess dischargeappearance

37

A


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III. Evaluation of Breast Pain


A = AnnotationPatient presents withbreast pain

A

Mammogram and/orultrasound at the discretion

of the clinician

no

Abnormalimaging?

Refer to Algorithm IV,"Radiologic Evaluation of

the Breast"

yes

Quantitative painassessment

no

Pain requiresintervention?

Initiate non-pharmacologicand/or pharmacologic

intervention(s)

Inform patient of nextscreening date

no

A

yes

A

A

A

46

47

4849

50

5152

53


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IV. Radiologic Evaluation of the Breast


A = Annotation

Abnormal screeningor diagnosticmammogram

Presence of:• Solid mass?• Abnormal

microcalcifications?• Architectural distortion?

Additional mammographicstudies and/or ultrasound if

neededA

yes

Abnormalitypresent but appears

to be probablybenign?

A

Repeat mammogramat 6-month intervals

x 2

yes

Progression?Report to ordering

provider

no

no

Increased risk?

A

Consider MRI

A

yes

yes

no

MassA

Calcification suspiciousfor cancer Architectural

distortion

Suspicious forcancer?

See Algorithm V, "Image-DirectedCore Needle Biopsy" and/or

Algorithm VI, "SurgicalEvaluation of the Breast"

yes

Ultrasound (if notalready performed)

no

A

Non-palpablesolid mass?

Fits benigncriteria?

yesRepeat mammogramin six months

yes

Findingsabnormal?

See Algorithm V, "Image-DirectedCore Needle Biopsy" and/or

Algorithm VI, "SurgicalEvaluation of the Breast"

yes

• Return to screeningmammography

• Report to orderingprovider

A

no

Indications foraspiration?

• Internal echo• Palpability• Complex

Residualmass?

no

yes

Aspirate and single-view mammogram

A

no

yes

A

no

A

A

Ano

no

Sort abnormalities

A

54

55

59

60

61

6256

57

5864

63

65

66

68

67

69

70

75

76

77

78

74

7172

73

A


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A = Annotation

V. Image-Directed Core Needle Biopsy

Patient referred forimage-directed biopsy

A

Cancer? Definitive therapyyes

A

no

Surgical consult foropen biopsy

yes

A

Are calcificationspresent on specimen

radiograph?

A

Rebiopsy by core oropen biopsy

no

A

Is mass benignfibroadenoma?

yes

Yearly screeningmammogram or refer

to surgeon

yes

Mammogram in 6-12months, then annually for

3 yearsA

no

Stable?Open biopsy or repeat

image-guided coreneedle biopsy

A

Inform patient of nextscreening date

A

yes

no

Assure pathology andradiology conclusions

are concordant

Lobular neoplasia, ductalhyperplasia with atypia,phylloides tumor, lobularcarcinoma in situ (LCIS),

papillary lesions?

no

79

80

81

82

83

84

85

86

87 88

89

90

91

92

A


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VI. Surgical Evaluation of the Breast


A = AnnotationPatient referred to surgeon for evaluation

Palpable mass Breast painSpontaneous nipple

discharge

Abnormalmammogram,

ultrasound or MRI

Suspicious solid mass?Abnormal

microcalcifications?Progressive changes?

Architectural distortion?

yes

Aspirate mass ifsymptomatic

Repeat mammogram in6 months

See Algorithm IV,"Radiologic

Evaluation of the Breast"

noResidual mass orbloody aspirate?

yesBenignCancer

Lobular neoplasia,ductal hyperplasia

with atypia,phylloides tumor,

lobular carcinoma insitu (LCIS), papillary

lesions

Return in 6months for

breastexamination

Stable, benignor regression

Progression

Inform patient ofnext screening date

Re-examine in 4-6weeks

no

Does mass recur?yes no

A A

A

A

A

A

A

A

A

A

Consider imagingprior to aspiration

A

See Algorithm III,"Evaluation ofBreast Pain"

See Algorithm II,"Evaluation of the

Breast for SpontaneousNipple Discharge"

Open biopsy

A

Image-directed oropen biopsy

93

94

95

96

97

98

99100

101

102

103

104

105

106

Image-directedbiopsy

A

107

113111

109

108

110

Definitivetherapy

A

112 114

116 115

117

A


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Table of Contents


Work Group LeaderMichael Nelson, MDRadiology, University of MN PhysiciansWork Group MembersFamily PracticeTara Springer, DOFairview Health ServicesInternal MedicineDeepti Pandita, MDPark Nicollet Health ServicesRadiologyJoseph Tashjian, MDSt. Paul RadiologySurgeryJudy Boughey, MDMayo ClinicAudrey Park-Skinner, MDSt. Mary's/Duluth Clinic Health SystemOmer Sanan, MD Aspen Medical GroupNursingBarbara Maclin, RN, OCHealthPartners Medical GroupLisa Starr, CNPSt. Mary's/Duluth Clinic Health SystemMeasurement and Implementation AdvisorSylvia Robinson, BSN, MBAICSIFacilitator Linda Setterlund, MA, CPHQICSI

Algorithms and Annotations ....................................................................................... 1-28Algorithm (Evaluation by Primary Care of Patient with Symptoms of Potential Breast Disease) ........................................................................ 1Algorithm (I. Evaluation of Breast Mass) .......................................................................... 2Algorithm (II. Evaluation of the Breast for Spontaneous Nipple Discharge) .................... 3Algorithm (III. Evaluation of Breast Pain) ......................................................................... 4Algorithm (IV. Radiologic Evaluation of the Breast) ......................................................... 5Algorithm (V. Image-Directed Core Needle Biopsy) ......................................................... 6Algorithm (VI. Surgical Evaluation of the Breast) ............................................................ 7Foreword

Scope and Target Population ......................................................................................... 9Clinical Highlights and Recommendations .................................................................. 9Priority Aims ................................................................................................................. 9Key Implementation Recommendations ..................................................................... 10Related ICSI Scientific Documents ............................................................................ 10Disclosure of Potential Conflict of Interest ..................................................................11Introduction to ICSI Document Development ....................................................... 11-12Description of Evidence Grading................................................................................ 12

Annotations ................................................................................................................. 13-28Annotations (Evaluation by Primary Care of Patient with Symptoms of Potential Breast Disease) ............................................................ 13-14Annotations (I. Evaluation of Breast Mass) ........................................................... 14-15Annotations (II. Evaluation of the Breast for Spontaneous Nipple Discharge) ..... 15-17Annotations (III. Evaluation of Breast Pain) ......................................................... 17-20Annotations (IV. Radiologic Evaluation of the Breast) ......................................... 20-24Annotations (V. Image-Directed Core Needle Biopsy) ......................................... 24-26Annotations (VI. Surgical Evaluation of the Breast) .......................................... 26-28

Supporting Evidence.................................................................................................... 29-39Brief Description of Evidence Grading ............................................................................ 30References ...................................................................................................................31-34Conclusion Grading Worksheets .................................................................................35-39

Conclusion Grading Worksheet A – Annotation #58 (Magnetic Resonance Imaging) ........................................................................35-39

Support for Implementation ..................................................................................... 40-47Priority Aims and Suggested Measures ............................................................................ 41

Measurement Specifications ....................................................................................... 42Key Implementation Recommendations .......................................................................... 43Knowledge Resources ...................................................................................................... 44Resoures Available ...................................................................................................... 45-47


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Foreword

Scope and Target PopulationThis guideline applies to all adults who have a breast abnormality.

Clinical Highlights and Recommendations

• It is imperative that communications between the radiologic and surgical consultants and the primary care provider are thorough and consistent. (Algorithm I, Annotation #13)

• A bloody tap or a persistent mass following aspiration of a palpable dominant mass should be referred to a surgeon regardless of negative imaging. (Algorithm I, Annotation #23)

• Patients with a spontaneous bloody or watery discharge should be referred to a radiologist for imaging studies and a surgeon if appropriate. (Annotations #35, 36)

• The risk of cancer with a negative evaluation for breast pain is less than 1%. (Algorithm III, Annotation #52)

• Any questionable pathologic findings from image-directed biopsy requires a surgical consultation. (Algorithm V, Annotation #83)

Priority Aims

1. Reduce the length of time between first knowledge of a breast abnormality and diagnostic resolution.

2. Ensure that a bloody tap or a persistent mass following aspiration of a palpable dominant mass is referred to a surgeon regardless of negative imaging.

3. Ensure that patients with spontaneous bloody or watery discharge have a mammogram (with or without an ultrasound) and are referred to a surgeon or radiologist.

4. Ensure that needle biopsies demonstrating pathologic findings are followed by performance of an open biopsy.

5. Ensure that all women with a breast concern that is indeterminate or vague will have short-term follow-up clinical assessment.



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Key Implementation RecommendationsThe following system changes were identified by the guideline work group as key strategies for health care systems to incorporate in support of the implementation of this guideline.

1. Primary Care, Radiology and Surgery:

Establish a communication plan to include all providers involved in the patient's treatment plan:

• Patients undergoing biopsy should have results reported to the radiologist and/or surgeon performing the procedure, as well as the primary care provider.

2. Primary Care:

Establish a system for education of all female patients regarding self breast examination and age-appro-priate mammographic screening intervals.

Develop a system for timely assessment of palpable breast masses including necessary imaging studies, follow-up, and referral to radiology or surgery for biopsy.

3. Radiology:

Establish a process that ensures that abnormalities of the breast are accurately identified and sorted, and that all appropriate radiologic imaging studies necessary to the evaluation process are efficiently completed.

4. Surgery:

Establish a process for timely completion of evaluation of breast lesions and provide additional surgical breast consultation as needed.

5. Documentation:

Develop a system to document time frame from receipt of pathology to patient information.

• Telephone call documentation

Related ICSI Scientific DocumentsRelated Guidelines

• Preventive Services for Adults

• Assessment and Management of Acute Pain

• Assessment and Management of Chronic Pain

Technology Assessment Reports

• Image-Directed Biopsies of Breast Lesions (#17, 1999)

• Lymphatic Mapping with Sentinel Lymph Node Biopsy for Breast Cancer (#45, 2002)

• Bilateral Prophylactic Mastectomy (#46, 1999)

• Computer-Aided Detection for Breast Cancer (#84, 2004)

• Genetic Screening for Breast Cancer (#33, 1997)

• Magnetic Resonance Imaging (MRI) for the Detection of Breast Abnormalities (#81, 2003)

Diagnosis of Breast Disease Foreword Twelfth Edition/January 2008


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Disclosure of Potential Conflict of InterestIn the interest of full disclosure, ICSI has adopted the policy of revealing relationships work group members have with companies that sell products or services that are relevant to this guideline topic. The reader should not assume that these financial interests will have an adverse impact on the content of the guideline, but they are noted here to fully inform readers. Readers of the guideline may assume that only work group members listed below have potential conflicts of interest to disclose.

No work group members have potential conflicts of interest to disclose.

ICSI's conflict of interest policy and procedures are available for review on ICSI's Web site at http://www.icsi.org.

Introduction to ICSI Document DevelopmentEach guideline, order set and protocol is developed by a 6- to 12-member work group that includes physi-cians, nurses, pharmacists and other health care professionals relevant to the topic, along with an ICSI staff facilitator. Ordinarily, one of the physicians will be the leader. Most work group members are recruited from ICSI member organizations, but if there is expertise not represented by ICSI members, one or two members may be recruited from medical groups or hospitals outside of ICSI.

Prospective work group members are asked to disclose any potential conflicts of interest relevant to the topic of the document; disclosure forms are reviewed for unacceptable conflicts. At the beginning of each work group meeting, the potential conflicts of interest that have been disclosed are reviewed by the work group.

The work group meets for seven to eight three-hour meetings to develop the guideline. A literature search and review is performed and the work group members, under the coordination of the ICSI staff facilitator, develop the algorithm and write the annotations and literature citations.

Once the final draft copy of the guideline is developed, the guideline goes to the ICSI members for critical review.

Critical Review ProcessThe purpose of critical review is to provide an opportunity for the clinicians in the member groups to review the science behind the recommendations and focus on the content of the guideline. Critical review also provides an opportunity for clinicians in each group to come to consensus on feedback they wish to give the work group and to consider changes needed across systems in their organization to implement the guideline.

All member organizations are expected to respond to critical review guidelines. Critical review of guidelines is a criterion for continued membership within ICSI.

After the critical review period, the guideline work group reconvenes to review the comments and make changes, as appropriate. The work group prepares a written response to all comments.

ApprovalEach guideline, order set and protocol is approved by the appropriate steering committee. There is one steering committee each for Respiratory, Cardiovascular, Women's Health and Preventive Services. The Committee for Evidence-Based Practice approves guidelines, order sets and protocols not associated with a particular category. The steering committees reviews and approves each guideline based on the following:

• Member comments have been addressed reasonably.



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• There is consensus among all ICSI member organizations on the content of the document.

• To the extent of the knowledge of the reviewer, the scientific recommendations within the document are current.

• Either a critical review has been carried out, or to the extent of the knowledge of the reviewer, the changes proposed are sufficiently familiar and sufficiently agreed upon by the users that a new round of critical review is not needed.

Once the guideline, order set or protocol has been approved, it is posted on the ICSI Web site and released to members for use. Guidelines, order sets and protocols are reviewed regularly and revised, if warranted.

Document Revision ProcessICSI scientific documents are revised every 12-36 months as indicated by changes in clinical practice and literature. Every six months, ICSI checks with the work group to determine if there have been changes in the literature significant enough to cause the document to be revised earlier than scheduled.

Prior to the work group convening to revise the document, ICSI members are asked to review the document and submit comments. During revision, a literature search of clinical trials, meta-analysis and systematic reviews is performed and reviewed by the work group. The work group meets for one to two three-hour meetings to review the literature, respond to member organization comments, and revise the document as appropriate.

If there are changes or additions to the document that would be unfamiliar or unacceptable to member organi-zations, it is sent to members to review prior to going to the appropriate steering committee for approval.

Evidence Grading SystemA. Primary Reports of New Data Collection:

Class A: Randomized, controlled trial

Class B: Cohort study

Class C: Non-randomized trial with concurrent or historical controls Case-control study Study of sensitivity and specificity of a diagnostic test Population-based descriptive study

Class D: Cross-sectional study Case series Case report

B. ReportsthatSynthesizeorReflectuponCollectionsofPrimaryReports:

Class M: Meta-analysis Systematic review Decision analysis Cost-effectiveness analysis

Class R: Consensus statement Consensus report Narrative review

Class X: Medical opinion



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Algorithm Annotations

Evaluation by Primary Care of Patient with Symptoms of Potential Breast Disease Algorithm Annotations

2. Perform History and Physical Exam for Breast-Related SymptomsSee also Annotations #32, "Patient Presents with Spontaneous Nipple Discharge" and #46, "Patient Presents with Breast Pain" for specific symptom-related history and physical.

Guidelines for primary care evaluation are initiated with a history aimed at uncovering and characterizing any breast-related symptoms. Likewise, a risk assessment should also be undertaken for identified risk factors: personal history of any breast cancer, personal history of ductal hyperplasia with atypia on previous breast biopsies, or family history of breast cancer in first-degree relatives. A high-risk patient would be one with a mother, sister or daughter who had breast or ovarian cancer before age 50, or a history of prior radiation before age 30, or is a carrier of mutated breast cancer genes (Smith, 2003 [R]). She should be referred for genetic counseling and consider testing.

A physical examination should include inspection of the breast for any evidence of ulceration or contour changes. This includes examining the nipple for Paget's disease, and the presence of breast nodule(s), nipple disease, evidence of infection and/or spontaneous discharge. Palpation should be performed both in the upright and supine position to determine the presence of a palpable mass (Barton, 1999 [C]). Abnormalities detected during a clinical breast examination – such as masses or nodules, nipple discharge or inflammatory changes – require thorough evaluation and prompt treatment.

9. Is Screening Mammogram Due?Following completion of a physical examination in which no palpable mass is identified, a routine screening mammogram should be obtained if one has not been done within the recommended interval.

Refer to the ICSI Preventive Services for Adults guideline for mammography screening intervals.

10. Screening MammogramRegular mammographic screening has been shown to reduce incidences in breast cancer. The results of the mammogram are provided to the primary care physician for reporting to the patient (Fletcher, 2003 [R]; Jonsson, 2000 [C]; Tabar, 2001 [A]).

12. Complete All Radiologic RecommendationsShould any abnormality be uncovered, it will be the responsibility of the radiologist to complete any addi-tional imaging studies required for the complete radiographic characterization of the lesion. The radiologist should make certain that all recommendations including additional views, follow-up films, ultrasounds, etc., have been completed prior to referral to surgery. However, it is important that the provider ordering the mammogram review the results of these studies to fully understand the impression of the radiologist, and to assure that all recommendations by the radiologist have been completed within the department of radiology. Should the recommendation be made by radiology that a surgical consultation is warranted, it will be the responsibility of the primary care provider to establish this referral.

See Algorithm IV, "Radiologic Evaluation of the Breast."



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13. Inform Patient of Next Screening DateRefer to the ICSI Preventive Services for Adults guideline for recommended mammography screening intervals.

I. Evaluation of Breast Mass Algorithm Annotations

15. Indeterminant or Dominant Mass?A dominant mass is a palpable finding that is discrete, solid and clearly different than the surrounding parenchyma. Should a palpable mass be identified, it should be characterized as to whether it represents a dominant (i.e., discrete) mass that requires immediate evaluation. Should physical examination demonstrate a palpable mass that is not clearly discrete and dominant (indeterminant), its size, location and character should be documented in anticipation of follow-up examination (Pruthi, 2001 [R]).

16. Perform Ultrasound and/or Diagnostic MammogramPrior to the referral, a mammogram should be obtained. For women under age 50 digital mammography is preferrable for dense breast tissue (Pisano, 2005 [C]). Also see Annotation #54, "Abnormal Screening or Diagnostic Mammogram."

21. Consider Aspiration if Symptomatic or Refer to the Appropriate ConsultantAspiration if a pure cyst is only necessary if the cyst is symptomatic and may be performed by the primary care provider or by the appropriate consultant (radiologist, surgeon). A successful aspirate would yield a non-bloody fluid with complete resolution of the dominant mass. The breast skin is prepped with alcohol. Then, with the lesion immobilized by the non-operating hand, an 18-25 gauge needle mounted on a 10 cc syringe is directed to the central portion of the mass for a single attempt at aspiration. If the lesion is a simple cyst, the mass should completely resolve.

Cyst fluid should be examined cytologically if it is bloody or unusually tenacious. Typical watery green fluid may be discarded.

For recommendations regarding appropriate further workup and possible biopsy, refer to the following algorithms in this guideline:

• Algorithm IV. Radiologic Evaluation of the Breast

• Algorithm V. Image-Directed Core Needle Biopsy

• Algorithm VI. Surgical Evaluation of the Breast

The importance of communication between the radiologic and surgical consultants and the primary care provider cannot be overstated. Patients undergoing biopsy should have results reported to both the radiologist or surgeon performing the biopsy and to the primary care provider. More importantly, patients who do not require biopsy following radiologic or surgical consultation should be returned to the routine screening process. This process is under the supervision of the primary care provider. Therefore, it is absolutely necessary for the primary care provider to know when the patient reenters the routine screening population. In the event that new symptoms arise or occur during the screening interval, the patient should be evaluated by the primary care provider using the primary care evaluation process of this guideline.

Diagnosis of Breast Disease Algorithm Annotations Twelfth Edition/January 2008


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23. Residual Mass or Bloody Aspirate?Should the mass remain following the attempt at aspiration or should a bloody aspirate be obtained during the process, the presence of a malignancy cannot be ruled out. Patients with a residual mass or a bloody aspirate should be referred to surgery for further consultation, workup and possible biopsy.

Surgical excision should be performed for those cysts with bright red bloody aspirate and those that do not completely resolve with aspiration.

Bloody aspirate should be considered for cytology.

(Schnitt, 1996 [R])

24. Follow-up Clinical Breast Exam in 4-6 Weeks at Discretion of ClinicianIf no residual mass or blood aspirate remains, a repeat examination should be performed in 4-6 weeks at the discretion of clinician. The optimum time for this exam is after one menstrual cycle.

28. Residual Mass?Persisting palpable masses not resolving in one month and all recurring cystic masses should be referred to radiology for further evaluation. If subsequent ultrasound is unable to confirm the presence of a benign cystic lesion, or if the lesion is worrisome to the patient, surgical consultation is indicated.

29. Inform Patient of Next Screening DateIf no mass is apparent at the time of this examination, the patient should be informed of the appropriate date of her next routine screening evaluation.

Refer to the ICSI Preventive Services for Adults guideline for mammography screening intervals.

II. Evaluation of the Breast for Spontaneous Nipple Discharge Algorithm Annotations

32. Patient Presents with Spontaneous Nipple DischargeGuidelines for primary care evaluation of patient presenting with complaint of spontaneous nipple discharge are initiated with a history aimed at uncovering and characterizing any breast-related symptoms, including whether discharge has been spontaneous, persistent, unilateral vs bilateral, single or multiple ducts, its rela-tion to menses, pregnancy, exercise, trauma, medications and/or thyroid disorders.

The site around nipple should be examined for discharge upon pressure. Hemoccult test for blood may also be administered.

(Leis Jr, 1989 [R]; Schnitt, 1996 [R]; Urban, 1978 [D]; Winchester, 1996 [R])

33. Perform Mammogram/UltrasoundA mammogram should be obtained. An ultrasound may be helpful to locate an intraductal nodule or dilated duct.

(Winchester, 1996 [R])



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35. Complete All Radiologic RecommendationsA patient with an abnormal mammogram or ultrasound should be further evaluated within the department of radiology to best characterize the lesion, and then be referred to surgery if appropriate. Make certain that all recommendations for additional views, ultrasound examinations, and follow-up studies have been obtained prior to referral to surgery. A ductogram may be completed as part of the radiologic workup.

37. Assess Discharge AppearancePathologic discharges are spontaneous, may be associated with a mass, and are usually bloody, blood-containing or sometimes watery. They are usually unilateral, involve a single duct, and are more worrisome in patients greater than 50 years old.

Physiologic discharges usually are bilateral, involve multiple ducts, are multicolored or milky, sticky and those that are stimulated rather than spontaneous.

38. Clear or Bloody DischargeBloody or, less commonly, clear watery discharge raises the possibility of cancer, although the most common causes of hemoccult-positive discharges are benign. The most common causes of bloody nipple discharge are intraductal papilloma (45%), duct ectasia (36%), carcinoma (8%-15%), and infection and other causes (5%-10%).

Bloody discharge needs further evaluation to determine the etiology.

(Bauer, 1998 [D]; Schnitt, 1996 [R]; Winchester, 1996 [R])

39. Refer to Surgeon (+/- Ductography)Most pathologic nipple discharges should be treated with duct excision. The use of ductography is contro-versial, and depends on the decision of the surgeon and radiologist.

(Dennis, 2000 [D]; Kenney, 2003 [R]; Klein, 2002 [R])

40. Milky, Yellow, Brown, Green, Gray DischargeThe appearance of the fluid generally correlates with the cause. Yellow, brown, green or gray fluid is asso-ciated with fibrocystic change in most patients. Purulent discharge can result from duct ectasia or partial duct obstruction.

43. Hormonal EvaluationProlactin and TSH levels are obtained to determine an endocrinologic basis for the nipple discharge. A prolactinoma typically causes a milky or clear discharge bilaterally (Schnitt, 1996 [R]; Winchester, 1996 [R]).

Assay should be performed for prolactin and TSH as both of these pituitary hormones may induce galac-torrhea, may have a reversible cause, and may likewise reflect further underlying pathology (e.g., pituitary adenoma, hypothyroidism, etc.) (Schnitt, 1996 [R]; Winchester, 1996 [R]).



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45. Follow-Up Visit Scheduled at the Discretion of the Treating ClinicianIf the mammogram and the endocrinologic screening studies are normal, the patient should schedule a follow-up visit at the discretion of the responsible clinician.

If the evaluation at the time of that follow-up visit fails to reveal any palpable or visible abnormalities, the patient should be returned to the routine screening process.

III. Evaluation of Breast Pain Algorithm Annotations

46. Patient Presents with Breast PainKey Points:

• The information gathered should include location and severity of pain, relationship to menstrual cycle or physical activities and hormonal influences.

• As appropriate, an exam directed at the cervical and thoracic spine, chest wall and upper extremities may be helpful in assessing other causes of pain.

Breast pain is one of the most common symptoms evaluated in primary care, surgery or specialty breast clinics. Approximately 41% to 69% of women report having experienced breast pain (Ader, 1997 [D]). Breast pain may interfere with daily activities, relationships and quality of life.

History and Physical ExamThe symptom of breast pain prompts many patients to make an appointment for a medical examination out of concern for the possible presence of breast cancer. A patient history is directed toward identifying and characterizing breast-related symptoms. The information gathered should include location and severity of pain, relationship to physical activities or the menstrual cycle, and interference with routine activi-ties. Hormonal influences, such as pregnancy, use of contraceptives and hormone therapy should also be reviewed. Obtaining a history may also provide information identifying non-breast sources of pain. The patient should also be asked about any new medications or those that can be associated with breast pain should be noted. Risk assessment for breast cancer should include the appropriate reproductive, medical and family history.

A clinical examination of the breast should be performed with careful inspection and palpation of each breast, nipple-areolar complex and regional lymph nodes. Localized, generalized or bilateral breast tenderness should be noted. In addition to palpating the breasts while the patient is supine, examining the breasts while the patient is sitting or lying on her side may allow breast and chest wall tenderness to be distinguished.

Laboratory studies are generally not useful. A pregnancy test, however, should be considered in women of reproductive age if the history or examination suggests pregnancy. Other hormone levels (e.g., estrogen, progesterone and prolactin) are typically normal in patients with breast pain.

Breast pain may occur as a result of pregnancy, mastitis, trauma, thrombophlebitis, macrocysts, benign tumors or cancer; however, only a minority of breast pain is explained by these conditions. Most breast pain is of unknown cause. A variety of conditions can result in pain perceived in the breast. A variety of conditions can be revealed as a result of a directed history and physical. As appropriate, an exam directed at the cervical and thoracic spine, chest wall, shoulders and upper extremities, sternum, heart, lungs and abdomen may be helpful in assessing other potential causes of the pain.

(Ader, 1997 [D]; Ader, 2001 [D]; Dixon, 1999 [R])



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Breast pain is commonly categorized into three classifications (Smith, 2004 [R]):

• Cyclic mastalgia occurs in premenopausal women and is clearly related to the menstrual cycle. The pain is typically bilateral and diffuse, often located in the upper outer quadrants of the breasts with frequent radiation to the axilla and the ipsilateral arm. Occasionally, breast pain may be unilateral or more intense in one breast.

• Non-cyclic mastalgia may involve continuous or intermittent pain that does not concur with the menstrual cycle. The pain is more often unilateral and localized with the pain in the lower inner portions of the breast. Non-cyclic breast pain generally occurs in older women, with symptoms often occurring in postmenopausal women.

• Non-mammary pain may present with the symptom of breast pain. Following the history and physical exam, differentiating breast pain and pain radiating from the chest wall or another site is usually straightforward. Occasionally the origin of pain is not evident, or there are multiple origins of pain, making evaluation more challenging.

47. Mammogram and/or Ultrasound at the Discretion of the ClinicianImaging studies are frequently utilized in the evaluation of the breast. A mammogram should be considered especially in women with a family history of early breast cancer. Ultrasound may be useful for focal breast pain in both younger and older women. Subclinical breast cancer has been reported to occur in 2%-7% of women who have pain as the only symptom. It is unclear whether the pain is related to the cancer or whether this symptom initiates a breast evaluation in which an asymptomatic cancer is identified. Breast pain secondary to malignancy is typically unilateral and persistent. In these cases, imaging with directed ultrasound may be a more valuable assessment tool (Duijm, 1998 [B]; Smith, 2004 [R]).

50. Quantitative Pain AssessmentBreast pain may be difficult to assess as the symptoms may appear and subside without provocation, with certain activities or with the menstrual cycle. An attempt must be made to measure the amount and severity of the patient's breast pain over time, which is difficult as there is no standard unit of pain. Prospective assessment of breast pain may be a valuable tool when considering an intervention. Possible tools to docu-ment an individual's pain include pain rating instruments, a daily breast pain chart or a diary to document the occurrence and severity of pain, use of medications and interferences with lifestyle. These tools are particularly important in making an initial diagnosis of cyclic mastalgia and response to therapy (Ader, 2001 [D]; Dixon, 1999 [R]; Smith, 2004 [R]). For more information on pain assessment see ICSI Assessment and Management of Acute Pain and Assessment and Management of Chronic Pain guidelines.

52. Initiate Non-Pharmacologic and/or Pharmacologic Intervention(s)• The first line of treatment for breast pain is to reassure the patient that she does not have breast cancer.

The risk of malignancy following a negative examination has been estimated to be only 0.5%, so reassurance following a negative evaluation is appropriate (Smith, 2004 [R]). Approximately 15% of women choose a treatment intervention to reduce the symptom of pain. During encounters for breast pain, the patient's description of the pain, quantitative assessment of the pain and decisions regarding reassurance, follow-up or therapeutic intervention should be documented.

• Few women will require treatment with more than reassurance and well-tolerated medications such as evening primrose oil. For those with severe, refractory breast pain, the significant side effects of some of these medications must be balanced against the potential benefit in ameliorating breast discomfort and pain.



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• Non-pharmacologic interventions for breast pain are appropriate for women with breast pain. Although there has been little scientific investigation into the effectiveness of these non-pharmacologic approaches, they are frequently found to improve breast pain symptoms in clinical practice and are of low risk and expense to the patient.

Potential non-pharmacologic therapies include:

Mechanical support

A professionally fitted support bra, irrespective of age, cup size or underlying breast disease has been shown to relieve breast pain even in patients who have not responded to hormonal treatments. Support bras are recommended for exercise. A soft supportive bra during sleep may also improve symptoms.

Lifestyle changes

Lifestyle changes such as smoking cessation, stress reduction and improving coping skills may be possible low-risk interventions. Hot packs, cold packs and massage may also relieve symptoms.

The effectiveness of dietary measures is unclear. Studies have demonstrated improvement in breast pain symptoms following dietary reduction of saturated fat. Caffeine reduction or elimination has been found to be helpful by some patients, particularly those who consume large quantities of caffeine. Clinical studies have not shown this to be a consistent outcome.

Pharmacologic interventions

The decision whether to treat breast pain along with the selection of a particular agent to utilize requires balancing the need for symptom relief against the likelihood of medication side effects. If considering a pharmacologic therapy, consult with a specialist should be considered.

Pharmacologic interventions may include the adjustment of medications that may be contributing to breast pain, such as oral contraceptives, hormone therapy, spironolactone and others. Eliminating or decreasing the dose of estrogen in an oral contraceptive or hormone regimen is often effective.

Possible pharmacologic therapies include:

Evening primrose oil

Evening primrose oil is often used as an initial treatment for breast pain because of its low incidence of side effects and positive response rates for cyclic and non-cyclic pain. It is rich in gamma-linolenic acid and is believed to alter the saturated/polyunsaturated fat balance and decrease sensitivity to hormonal influences. The average dose is 2 x 500 mg soft-gel capsules three times a day for a minimum of three to four months.

Analgesics

Analgesics, such as ibuprofen, 400 mg every four to six hours may reduce breast pain.

Danazol

Danazol is the only medication that is labeled by the United States Food and Drug Administration for treatment of breast pain. Danazol is an antigonadotropin with some androgenic activity. It is the only medi-cation that is labeled by the United States Food and Drug Administration for treatment of breast pain.

Danazol relieves breast pain in 75%-92% of women. A typical initial dose of 200 mg per day is recom-mended, with gradual tapering to an alternate day or luteal phase dosing; doses from 100-400 mg per day have also been described. Reported side effects are common and include hair loss, acne, decrease in voice pitch, weight gain, irregular menses and depression. There may also be a possible increase in venous throm-boembolic events. Barrier contraception must be utilized. Danazol administered in the luteal phase only



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has been found to relieve premenstrual breast pain in women with premenstrual syndrome with minimal side effect. It was not effective for other premenstrual syndrome symptoms (O'Brien, 1999 [A]).

Bromocriptine

One of the few hormonal abnormalities detected in breast pain has been an increase in thyrotropin induced prolactin secretion. Bromocriptine has been shown to decrease serum prolactin levels in normal and hyperprolactinemic women and may decrease dynamic secretion of prolactin in cyclic mastalgia patients. In several European studies, bromocriptine has shown significant decreases in breast pain (approximately 54%), as well as heaviness and tenderness in the breasts. Prolactin levels decline during therapy while estrogen, progesterone, testosterone and gonadotropin releasing hormones do not significantly change. Side effects are common and dose related, including nausea, vomiting, headache, dizziness and fatigue. An incremental dosing regimen is used beginning with 1.25 mg at bedtime, gradually increasing until a dose of 2.5 mg twice daily is reached. The beneficial effects lasted three to six months after bromocriptine was discontinued (Mansel, 1990 [A]).

Tamoxifen

Tamoxifen is a selective estrogen receptor modulator (SERM) utilized for the prevention and treatment of breast cancer. Response rates have demonstrated tamoxifen to be effective in reducing pain in 75%-90% women with cyclic and 56% of women with non-cyclic mastalgia in controlled trials. Tamoxifen has signifi-cant side effects with the principle concerns being from thromboembolic disease and endometrial cancer. Additional side effects include hot flashes, nausea, menstrual irregularity and vaginal dryness or discharge. The 10 mg daily dose of tamoxifen appeared to be as effective as the 20 mg daily dose with fewer side effects. Tamoxifen, like other hormonal interventions, should be reserved for women with severe mastalgia. Contraception must be utilized (Fentimen, 1988 [A]).

Other medications that have been found to be effective for the treatment of breast pain include goserelin, gestrinone, buserelin, leuprolide, quinagolide, cabergoline, thyroxine and topical nonsteroidal anti-inflam-matory agents. Medroxyprogesterone has shown variable results in the treatment of breast pain. In general, antibiotics, diuretics and most vitamins have not been effective in the treatment of breast pain (Ader, 2001 [D]; BeLieu, 1994 [R]).

53. Inform Patient of Next Screening DateRefer to the ICSI Preventive Services for Adults guideline for recommended mammography screening intervals.

IV. Radiologic Evaluation of the Breast Algorithm Annotations

54. Abnormal Screening or Diagnostic MammogramKey Points:

• It is recommended that an abnormal finding on routine mammography be evaluated under the direction of a radiologist.

Patients referred to the department of radiology most commonly enter for screening mammography. However, patients will occasionally be referred for diagnostic mammography, based on the presence of symptoms or findings on examination. In the event of an abnormal finding on mammography, it is recommended that a complete evaluation be undertaken within the department of radiology under the direction of a radiologist in order that a full characterization of the lesion will be provided back to the primary care physician ordering the original study. It will be the responsibility of the radiologist to complete the radiologic assessment of



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the patient within the department of radiology so that the best possible characterization of the abnormality may be provided to the primary care physician in an expeditious fashion. Any recommendations for referral to the department of surgery for possible biopsy should be made directly to the primary care physician. However, the ultimate responsibility to make the referral will rest with the primary care provider.

Nuclear medicine breast imaging

Because the PPV (Positive Predictive Value) of x-ray mammography is only 10%-30%, nuclear medicine may use a radionucleotide and high-resolution gamma camera to increase positive predictive values. Nuclear medicine imaging is a way of obtaining functional or metabolic information that could potentially decrease the number of unnecessary breast biopsies performed. This imaging technique may also work for patients with radiodense breasts.

New digital gamma cameras are now developed and available clinically to find smaller (2-3 mm) breast cancers.

Sentinel lymph node

Lymph scintimammography using Tc-99m colloids is used for preoperative and intraoperative localization of non-palpable breast tumors (Brem, 2007 [D]). Many breast centers are studying lymphoscintigraphy for the detection of a "sentinel node" in the evaluation of axillary lymph nodes for metastatic involvement (Bongers, 1999 [D]; Khalkhali, 1997 [D]). Refer to the ICSI Technology Assessment Report on Lymphatic Mapping with Sentinel Lymph Node Biopsy for Breast Cancer (#45, 2002).

Conclusion

Continued research in breast imaging will include collaboration among the fields of functional imaging, molecular biology and pathology. This research will create clinical studies for:

• Detecting earlier breast cancer

• More accurately quantifying the extent of disease

• Non-invasive evaluation of lymph node involvement

• Identifying residual microscopic disease

• Image biomarker or tumor-specific delivery of chemotherapy or radiosensitizing agents to breast tumors.

55. Presence of: Solid Mass? Abnormal Microcalcifications? Architectural Distortion?For patients referred with an abnormal mammogram, the surgeon or radiologist should determine whether the above suspicious changes are present. If not, the patient should report to ordering provider for follow-up and clinical exam. Recommend repeat mammogram in six to twelve months (Kerlikowske, 2003 [M]; Michell, 2003 [R]; Picca, 2003 [R]).

57. Increased Risk?Patients considered at increased risk may have one or more of the following (Smith, 2003 [R]):

• Previous breast biopsy demonstrating ductal hyperplasia with atypia

• Family history of breast or ovarian cancer in the patient's mother, sister or daughter under age 50, or breast cancer in male family member



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• Past, personal history of breast cancer

• A breast cancer gene

• Previous radiation to the chest (i.e., Hodgkin's Disease)

Consider genetic counseling for possible genetic testing and lifetime risk analyses – see ICSI Genetic Screening for Breast Cancer, TA #33.

58. Consider MRIThe use of MRI in the evaluation of breast disease has progressed rapidly over the last several years. MRI has previously been proven extremely useful in the evaluation, staging and monitoring of breast cancer and other breast problems. Recently, however, several studies have also demonstrated its ability to detect early breast cancer in high-risk women (screening). This has prompted the American Cancer Society to issue formal guidelines for Breast MRI screening of high risk women IN ADDITION to the recommended yearly mammogram. Below is a synopsis of the new guidelines along with a reference to the recent review (Saslow, 2007).

The following women SHOULD undergo yearly breast MRI screening* beginning at or around 30 years of age:

• Known carriers of BRCA 1 or BRCA 2 mutations

• First-degree relatives with known BRCA 1 or BRCA 2 mutations

• Clinical lifetime risk estimated at greater than 20% using clinical risk estimator (the Gail, Claus or BRCAPRO models are among the tools suggested)

• Known Cowden's, Li-Fraumeni or Bannayan-Riley-Ruvalcaba syndrome or first-degree affected relative

* Recommended at six-month offset interval from yearly mammogram

(Saslow, 2007 [R])

In women at high-genetic or -familial risk of breast cancer, MRI has high sensitivity (up to 94%) for the detection of breast cancer when used as an adjunct to mammography. This increase in sensitivity may lead to an earlier diagnosis of malignant breast lesions. However, MRI and mammography combined may lead to an increase in false positives, resulting in a higher rate of benign biopsies. At this time there are no studies on the differential effect of screening modalities on mortality or long-term outcomes. [Conclusion Grade II: See Conclusion Grading Worksheet A – Annotation #58 (Magnetic Resonance Imaging)] (Kriege, 2004 [C]; Lehman, 2005 [C]; MARIBS, 2005 [C]; Stoutjesdijk, 2001 [C]; Warner, 2004 [C])

Gadolinium warning:

In patients who receive gadolinium contrast media used in MRI, there is the potential for renal toxicity and the rare complication (3%-5% risk in patients with moderate to end-stage renal disease) of life-threatening nephrogenic systemic fibrosis.

It is recommended that gadolinium use be avoided when possible in patients with advanced renal disease.

Evidence is inconclusive regarding the following situations and DOES NOT YET SUPPORT routine breast MRI screening:

• Clinical lifetime risk estimated at 15%-20% using clinical risk estimator

• Previous LCIS, ALH, ADH biopsy results



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• Previous history of breast cancer including DCIS

• Extremely dense mammogram (density 4)

(Saslow, 2007 [R])

The following Web address provides access to the Gail clinical risk assessment: http://www.cancer.gov/bcrisktool/.

See ICSI Magnetic Resonance Imaging for the Detection of Breast Abnormalities, TA #81.

59. Additional Mammographic Studies and/or Ultrasound if NeededUpon obtaining an abnormal finding on a mammogram, the radiologist will determine whether further mammographic images or ultrasound are required for completion of the evaluation process. Alternatively, spot compression, magnification and/or ultrasound may be necessary to obtain further characterization of indeterminate lesions of the breast. These additional studies should be done with the radiologist present, to reduce the risk of patient recall for further studies necessary to evaluate the same lesion (Kolb, 2000 [R]; Kolb, 2002 [C]).

60. Abnormality Present but Appears to be Probably Benign?The term Probably Benign is an assessment category from the Breast Imaging and Reporting Data System (BI-RADS).

61. Repeat Mammogram at 6-Month Intervals x 2If further mammographic studies or sonography demonstrate findings that are felt to be Probably Benign, a repeat image of the breast at six months to document stability of low-risk, probably benign lesions. Perform mammograph again in another six months.

63. Sort AbnormalitiesUpon completion of these views, each and every abnormality uncovered for each independent lesion of the breast studied should be sorted according to the nature of the abnormality. The radiologist should classify the lesion as representing either suspicious microcalcifications, architectural distortion or a soft tissue mass.

64. MassIn the event that a soft tissue mass is identified in the mammogram, further studies are required to determine its relative risk for malignancy.

69. Ultrasound (if Not Already Performed)Should the mass not be immediately suspicious for cancer, an ultrasound should be performed (if not already) to determine whether or not the lesion is solid. (See Annotation #59, "Additional Mammographic Studies and/or Ultrasound if Needed.")

71. Fits Benign Criteria?A solid mass should be further characterized for its risk of malignancy according to three criteria. Lesions may be observed and followed with studies repeated in six months iftheyfitallthreeofthefollowingcriteria:

• Size less than 15 mm



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• Three or fewer lobulations

• More than 50% of the lesion margin appears well circumscribed in any view

Any lesion not fitting all three of the above criteria should be considered indeterminate and the patient should be referred for surgical evaluation regarding open biopsy or large core image-guided core biopsy.

(Dennis, 2001 [D]; Madabhushi, 2003 [C]; Stavros, 1995 [C])

75. Indications for Aspiration?If the ultrasound of the soft tissue mass demonstrates that this is a cystic lesion, the cyst should be further categorized according to the following criteria:

• Internal echoes

• Palpability within the region of the ultrasound-proven cyst

• Complex septated appearance

All cysts do not have to be aspirated if they meet benign criteria with an ultrasound exam.

If one or more of the preceding criteria is present, ultrasound-directed aspiration of the cyst may be indicated. Likewise, aspiration should be offered if the patient so requests.

76. Aspirate and Single-View MammogramFollowing cyst aspiration, a single-view mammogram may be performed to demonstrate complete resolution of the mammographic lesion. However, if the cyst completely disappears with ultrasound, a mammogram may not be necessary. If sufficiently complex, a pneumocystogram with post-mammogram view may be completed by radiology.

78. Return to Screening Mammography/Report to Ordering ProviderIf the lesion represents a simple cyst not fitting any of the criteria mentioned in Annotation #75, "Indica-tions for Aspiration?" the patient should be referred back to the screening process and completion of this evaluation should be reported to the ordering provider. Refer to the ICSI Preventive Services for Adults guideline for mammography screening intervals.

V. Image-Directed Core Needle Biopsy Algorithm Annotations

79. Patient Referred for Image-Directed BiopsyPatients referred for biopsy based on the presence of a mammographic and/or sonographic finding that is suspicious for or highly suggestive of malignancy will undergo either conventional open excisional biopsy (see Algorithm VI, "Surgical Evaluation of the Breast") or large core needle biopsy (Parker, 1996 [R]).

Large core imaging-guided breast biopsy is now the technique of choice in most institutions in the United States for biopsy of non-palpable breast masses and abnormal calcifications. Either stereotactic or ultrasound-guided breast biopsy may be used for reliable diagnosis of breast cancer. Stereotactic guidance is preferable for biopsy of calcifications. Most solid breast masses are amenable to large core needle biopsy with either stereotactic or ultrasound guidance. The location of the lesion, its visibility at ultrasound, equipment avail-ability and the radiologist's expertise will determine the approach selected.



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In some institutions, large core image-guided needle breast biopsy is performed for tissue diagnosis in cases of obvious cancer, as it saves the patient an additional surgical procedure, as well as expediting the diagnostic process.

Current changes in breast disease diagnosis

Over the past 20 years, advances in mammographic and sonographic technology have established a new subspecialty in radiology. Large core image-guided breast biopsy with larger needles and suction devices have revolutionized breast biopsy.

The following percutaneous techniques have been developed over the past 15 years:

• Fine-needle aspiration (FNA):

A 22- to 24-gauge needle is used for cytology. This is best used with a cytopathology department. It is also used in abnormal cyst aspiration (where fluid is obviously benign). FNA has limited use in most community hospitals because of inadequate specimens [in 30%-40% of FNA biopsies]. Therefore, large core image-directed breast biopsy has replaced most FNA biopsies (Mitnick, 1996 [D]; Norton, 1988 [C]; Pisano, 1998 [A]; National Cancer Institute Sponsored Conference, 1997 [R]).

• Image-guided 14-gauge spring-loaded devices:

They may be used with solid lesions greater than 3-5 cm in size; normally used with ultrasound guidance (Israel, 1995 [D]; Nguyen, 1996 [D]).

• Vacuum-assisted large core image-guided biopsy:

8, 9-, 11- or 12-gauge vacuum-assisted needles are used for microcalcifications, small masses or architectural distortion. Larger, vacuum-assisted electro-cautery devices may be used. These larger needles may help with avoiding undersampling and atypia diagnostic problems (Burbank, 1997 [C]; Dennis, 2000 [D]; Liberman, 1998 [D]; Meyer, 1997 [D]).

81. Definitive TherapyIf cancer is diagnosed, definitive therapy may be performed on the basis of stereotactic or image-guided needle biopsy alone.

83. Surgical Consult for Open BiopsyAny questionable pathologic findings or pathologic findings that do not correlate with the imaging are indications for repeat biopsy by excision to rule out the presence of occult malignancy in the region of the mammographic abnormality (Jackman, 1997 [C]).

85. Are Calcifications Present on Specimen Radiograph?To assure that an adequate core biopsy sample has been obtained for patients with suspicious microcalcifica-tions, evidence of microcalcifications must be present on the specimen micrographs following stereotactic biopsy (if calcifications were present on mammogram).

86. Rebiopsy by Core or Open BiopsyThe original specimen (pathology block) can be reexamined and recut for pathology exam if calcifications were noted. If calcifications cannot be demonstrated mammographically in the specimen, repeat biopsy, open or stereotactic, is necessary to assure that the abnormal mammographic lesion has been sampled. Biopsy must be repeated until the calcifications can be confirmed in the specimen.



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88. Yearly Screening Mammogram or Refer to SurgeonIf the mass is a fibroadenoma, then only yearly screening mammogram is necessary for follow-up. Benign fibroadenomas should be followed at routine screening intervals. However, if the patient is experiencing extreme pain and/or extreme tenderness, the fibroadenoma may be surgically removed or undergo cryotherapy (Kaufman, 2005 [D]; Littrup, 2005 [D]).

(de Paredes, 1998 [R]; Lindfors, 1998 [C])

89. Mammogram in 6-12 Months, Then Annually for 3 YearsFor all patients who have benign results from stereotactic or image-guided biopsy, a repeat mammogram of the involved breast in 6 to 12 months, then annually for three years, is necessary to document stability of the lesion. The radiologist should correlate the pathology results with the mammographic abnormalities for all patients. If they do not correlate, rebiopsy with image-directed core needle or open biopsy is necessary.

(Elvecrog, 1993 [C])

91. Open Biopsy or Repeat Image-Guided Core Needle BiopsyAny lesion that has grown or has become more dense on mammography, despite a previous benign core biopsy, must be rebiopsied or excised to rule out cancer.

92. Inform Patient of Next Screening DateRefer to the ICSI Preventive Services for Adults guideline for mammography screening intervals.

VI. Surgical Evaluation of the Breast Algorithm Annotations

93. Patient Referred to Surgeon for EvaluationPatients referred to the department of surgery for evaluation of breast disease will have undergone previous mammography that has demonstrated an abnormality warranting biopsy, or the patient may be referred on the basis of a physical finding uncovered in the primary care provider's office. It is the role of the surgeon to evaluate each and every abnormality uncovered in each patient. It is important for the surgeon to recognize that mammographically depicted lesions and palpable abnormalities may co-exist as separate entities within the breast. It is therefore important that each lesion be evaluated for its own merit, using this algorithm.

The importance of communication between the surgical consultant and the primary care provider cannot be overstated. Patients undergoing biopsy should have results reported both to the surgeon and the primary care provider. More importantly, patients who do not require biopsy following surgical consultation should be returned to the routine screening process. This process is under the supervision of the primary care provider. Therefore, it is absolutely necessary for the primary care provider to know when the patient reenters the routine screening population. In the event that new symptoms arise or occur during the screening interval, the patient should be evaluated by the primary care physician using the primary care evaluation process stated in Algorithm I, "Evaluation of Breast Mass" in this guideline.

94. Palpable MassPatients with palpable masses referred to surgery should first be evaluated to determine the presence of a dominant and discrete mass.



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95. Consider Imaging Prior to AspirationConsider an ultrasound and determine if the mass is solid or cystic.

96. Aspirate Mass if SymptomaticIf a palpable and discrete mass is present and symptomatic, an attempt should be made by the surgeon to aspirate the mass to rule out the presence of a simple cyst. An 18-25 gauge needle mounted on a syringe is inserted into an alcohol-prepped dominant breast mass for attempted aspiration.

(Bassett, 1997 [R])

97. Residual Mass or Bloody Aspirate?A simple cyst is one that resolves with aspiration of non-bloody fluid. If fluid is clear and non-spontaneous (i.e., as in compression mammogram) a workup is not always necessary, as this is benign. Surgical exci-sion should be performed for those cysts with bright red bloody aspirates and those that do not completely resolve with aspiration. A cyst that recurs may be re-aspirated, but the number of times this procedure can be repeated without surgical excision will depend upon the surgeon and patient's level of confidence that the lesion is benign.

Non-bloody fluids should be discarded, based on a study where no cancers were detected among 6,747 non-bloody specimens (Ciatto, 1987 [C]).

Among 401 patients with cystic masses, only 4 had cancer and all had either bloody fluid or a residual mass. This would be demonstrated by palpation or imaging (Hamed, 1989 [D]).

101. Spontaneous Nipple DischargePatients who present with nipple discharge or morphologic abnormality should be evaluated to determine the presence of bloody or unilateral discharge or palpable abnormality. Paget's disease of the nipple must be excluded. Open biopsy is recommended if any of these symptoms are present.

See Algorithm II, "Evaluation of the Breast for Spontaneous Nipple Discharge."

103. Breast PainPatients with breast pain referred to the surgical department should be evaluated for any focal findings identified on physical examination or on mammography. Any abnormalities uncovered warrant biopsy before consideration of symptomatic treatment of the process.

See Algorithm III, "Evaluation of Breast Pain."

106. Suspicious Solid Mass? Abnormal Microcalcifications? Progressive Changes? Architectural Distortion?

For patients referred with an abnormal mammogram, the surgeon should determine whether the above suspicious changes are present. If not, the patient should undergo a repeat mammogram in six months, at a minimum, to document stability of the lesion.



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107. Image-Directed BiopsyPatients referred for biopsy based on the presence of a mammographic and/or sonographic finding highly suspicious for cancer will undergo either conventional open excisional biopsy or image-directed needle core biopsy. (See Algorithm V, "Image-Directed Core Needle Biopsy.") Indications for biopsy are establishing a definitive diagnosis, finding multicentric lesions or associated intraductal pathology that may influence the choice to perform either mastectomy or breast conserving surgery for definitive treatment of the malignancy.

Image-directed core biopsy is the method of choice if sentinel lymph node study will be completed.

See the following algorithms in this guideline for other indications for open excisional breast biopsy:

• Radiologic Evaluation of the Breast

• Image-Directed Core Needle Biopsy

• Evaluation of the Breast for Spontaneous Nipple Discharge

110. Open BiopsyAny questionable pathologic findings are indications for repeat biopsy by excision to rule out the pres-ence of occult malignancy in the region of the mammographic abnormality.

112. Definitive TherapyIf cancer is diagnosed, definitive therapy may be performed on the basis of stereotactic core biopsy alone.

113. BenignBenign fibroadenomas should be followed at routine screening intervals. However, if the patient is experiencing extreme pain and/or extreme tenderness, the fibroadenoma may be surgically removed or undergo cryotherapy (Kaufman, 2005 [D]; Littrup, 2005 [D]).

114. Return in 6 Months for Breast ExaminationIf no focal findings are uncovered, a repeat examination within six months is warranted to rule out the presence of occult neoplastic process.

116. ProgressionIf the lesion is progressing in size and density or is otherwise worrisome, open biopsy is recom-mended.

117. Inform Patient of Next Screening DateRefer to the ICSI Preventive Services for Adults guideline for mammography screening intervals.


Availability of references

References cited are available to ICSI participating member groups on request from the ICSI office. Please fill out the reference request sheet included with your guideline and send it to ICSI.

29Copyright © 2008 by Institute for Clinical Systems Improvement

Released in January 2008 for Twelfth Edition. The next scheduled revision will occur within 24 months.

Contact ICSI at: 8009 34th Avenue South, Suite 1200; Bloomington, MN 55425; (952) 814-7060; (952) 858-9675 (fax)

Online at http://www.ICSI.org


Document Drafted Apr – Jun 1993

First Edition Jan 1994

Second Edition May 1995

Third Edition May 1996

Fourth Edition May 1997

Fifth Edition May 1998

Sixth Edition Feb 2000

Seventh Edition Feb 2001

Eighth Edition Dec 2001

Ninth Edition Dec 2002

Tenth Edition Dec 2003

Eleventh Edition Dec 2005

Twelfth Edition Begins Feb 2008

Supporting Evidence:


Original Work Group MembersJay Gutenkauf, MDFamily PracticeGroup Health, Inc.Ruth Johnson, MD Internal Medicine Mayo ClinicDee KemnitzBusiness Health Care Action GroupCarlson CompaniesCharles McCoy, MDFamily PracticePark Nicollet Medical Center

Michael Nelson, MDRadiology Park Nicollet Medical CenterJackie Rikhus, RNFacilitatorPark Nicollet Medical CenterCheri Rolnick, MD Measurement Advisor Group Health FoundationThamrong Suwam, MD Surgeon Group Health, Inc.

Jeanne M. Anderson, MD Family PracticeMinnHealth, P.A.John Bordwell, MD Family Practice Coon Rapids Medical CenterCandey Corey, MDOncologyGroup Health, Inc.John Gisvold, MD Radiology Mayo Clinic


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Brief Description of Evidence Grading

Individual research reports are assigned a letter indicating the class of report based on design type: A, B, C, D, M, R, X.

A full explanation of these designators is found in the Foreword of the guideline.

II. CONCLUSION GRADES

Key conclusions (as determined by the work group) are supported by a conclusion grading worksheet that summarizes the important studies pertaining to the conclusion. Individual studies are classed according to the system defined in the Foreword and are assigned a designator of +, -, or ø to reflect the study quality. Conclusion grades are determined by the work group based on the following definitions:

Grade I: The evidence consists of results from studies of strong design for answering the question addressed. The results are both clinically important and consistent with minor exceptions at most. The results are free of any significant doubts about generalizability, bias, and flaws in research design. Studies with negative results have sufficiently large samples to have adequate statistical power.

Grade II: The evidence consists of results from studies of strong design for answering the question addressed, but there is some uncertainty attached to the conclusion because of inconsistencies among the results from the studies or because of minor doubts about generalizability, bias, research design flaws, or adequacy of sample size. Alternatively, the evidence consists solely of results from weaker designs for the question addressed, but the results have been confirmed in separate studies and are consistent with minor exceptions at most.

Grade III: The evidence consists of results from studies of strong design for answering the question addressed, but there is substantial uncertainty attached to the conclusion because of inconsistencies among the results from different studies or because of serious doubts about generalizability, bias, research design flaws, or adequacy of sample size. Alternatively, the evidence consists solely of results from a limited number of studies of weak design for answering the question addressed.

Grade Not Assignable: There is no evidence available that directly supports or refutes the conclusion.

The symbols +, –, ø, and N/A found on the conclusion grading worksheets are used to designate the quality of the primary research reports and systematic reviews:

+ indicates that the report or review has clearly addressed issues of inclusion/exclusion, bias, generaliz-ability, and data collection and analysis;

– indicates that these issues have not been adequately addressed;

ø indicates that the report or review is neither exceptionally strong or exceptionally weak;

N/A indicates that the report is not a primary reference or a systematic review and therefore the quality has not been assessed.



www.icsi.org

�1

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��

Conclusion Grading Worksheet A – Annotation #58 (Magnetic Resonance Imaging)


Wor

k G

roup

’s C

oncl

usio

n: I

n w

omen

at h

igh-

gene

tic o

r fam

ilial

-ris

k of

bre

ast c

ance

r, M

RI h

as h

igh

sens

itivi

ty (u

p to

94%

) for

the

dete

ctio

n of

bre

ast c

ance

r whe

n us

ed a

s an

adju

nct t

o m

amm

ogra

phy.

Thi

s inc

reas

e in

sens

itivi

ty m

ay le

ad to

an

earli

er d

iagn

osis

of

mal

igna

nt b

reas

t les

ions

. H

owev

er, M

RI a

nd m

amm

ogra

phy

com

bine

d m

ay le

ad to

an

incr

ease

in fa

lse

posi

tives

, res

ultin

g in

a h

ighe

rra

te o

f ben

ign

biop

sies

. A

t thi

s tim

e th

ere

are

no st

udie

s on

the

diffe

rent

ial e

ffect

of s

cree

ning

mod

aliti

es o

n m

orta

lity

or lo

ng-te

rmou

tcom

es.

Con

clus

ion

Gra

de: II

Aut

hor/

Year

Des

ign

Type

Cla

ss

Qua

l-ity +,–,ø

Popu

latio

n St

udie

d/Sa

mpl

e Si

zePr

imar

y O

utco

me

Mea

sure

(s)/

Resu

lts (e

.g.,

p-va

lue,

conf

iden

ce in

terv

al, r

elat

ive

risk,

odd

s rat

io,

likel

ihoo

d ra

tio, n

umbe

r nee

ded

to tr

eat)

Aut

hors

' Con

clus

ions

/W

ork

Gro

up's

Com

men

ts (i

talic

ized

)

Stou

tjesd

ijket

al.,

200

1Se

nsiti

vity

and

spec

ifici

tyof

adi

agno

stic

test

C ø

-- 17

9 w

omen

from

a si

ngle

inst

itutio

n in

the

Net

herla

nds.

All

pts h

ad a

> 1

5% li

fetim

e ris

kof

bre

ast c

ance

r bas

ed o

n fa

mily

hist

ory

of b

reas

t and

/or o

varia

nca

ncer

or g

erm

line

mut

atio

n in

the

BRC

A1

or B

RCA

2 ge

nes.

-- Pa

tient

s with

a h

isto

ry o

fbr

east

canc

er o

r who

did

not

have

ade

quat

e fo

llow

-up

data

toco

nfirm

radi

olog

ic fi

ndin

gs w

ere

excl

uded

.---

Age

rang

e w

as 2

1-71

yea

rs.

--- 4

0 pt

s rec

eive

d m

amm

ogra

ms

only

, 49

had

rece

ived

MRI

onl

y,an

d 90

had

rece

ived

bot

hm

amm

ogra

phy

and

MRI

.--

Exam

s wer

e pr

ospe

ctiv

ely

inte

rpre

ted;

radi

olog

ists

inte

rpre

ting

the

resu

lts fr

om o

nete

st w

ere

blin

ded

to re

sults

from

the

othe

r mod

ality

.--

Brea

st Im

agin

g Re

port

ing

and

Dat

a Sy

stem

(BI-R

AD

S™) w

asus

ed, w

ith th

e fo

llow

ing

valu

es0:

add

ition

al im

agin

g re

quire

d1:

neg

ativ

e2:

ben

ign

3: p

roba

bly

beni

gn4:

sus

pici

ous a

bnor

mal

ity5:

hig

hly

sugg

estiv

e of

mal

igna

ncy

-- Bi

opsy

use

d as

fina

l dia

gnos

is

-- N

o di

ffere

nce

in a

ge o

r in

risk

cate

gory

bet

wee

npa

tient

s giv

en m

amm

ogra

phy

and

thos

e gi

ven

MRI

.--

13 m

alig

nant

tum

ors w

ere

dete

cted

(one

of t

heca

ncer

s was

a lo

w-g

rade

non

-Hod

gkin

’s ly

mph

oma)

Of t

he re

mai

ning

12,

MRI

det

ecte

d al

l of t

hem

with

mam

mog

raph

y m

issi

ng 7

tum

ors (

usin

g a

BI-R

AD

Sth

resh

old

of 3

).

The

sens

itivi

ty (s

ens)

, spe

cific

ity (s

pec)

, pos

itive

pred

ictiv

e va

lue

(PPV

) and

neg

ativ

e pr

edic

tive

valu

e(N

PV) a

re sp

ecifi

ed b

elow

BI-R

AD

S™ sc

ore

of 3

or h

ighe

r as o

pera

ting

poin

t

Sens

S

pec

PPV

N

PVM

amm

ogra

phy

4

2%

96%

3

3%

97%

MRI

100

%

93%

4

3%

100%

BI-R

AD

S™ sc

ore

of 4

or h

ighe

r as o

pera

ting

poin

t

Sens

S

pec

PPV

N

PVM

amm

ogra

phy

4

2%

99%

6

3%

97%

MRI

92%

9

8%

71%

99

.6%

Are

a un

der t

he re

ceiv

er-o

pera

tor c

hara

cter

istic

(RO

C) c

urve

(AU

C) f

or m

amm

ogra

phy

usin

g en

tire

BI-R

AD

S™ ra

nge

was

0.7

4 an

d fo

r MRI

was

0.9

9.D

iffer

ence

in A

UC

s bet

wee

n th

e gr

oups

was

stat

istic

ally

sign

ifica

nt (p

=0.0

03)

-- Th

e au

thor

s co

nclu

de th

at th

isre

tros

pect

ive

stud

y sh

ows

that

ann

ual

scre

enin

g w

ith b

reas

t MRI

is m

ore

accu

rate

than

mam

mog

raph

y in

the

early

det

ectio

n of

bre

ast c

ance

rs in

wom

en w

ith a

sign

ifica

nt h

ered

itary

risk

of s

uch

tum

ors.

-- Th

is re

sult

need

s to

be

conf

irmed

by

larg

er p

rosp

ectiv

e st

udie

s.--

Seve

ral f

acto

rs th

at th

e au

thor

sid

entif

ied

as p

ossi

bly

lead

ing

to b

ias

incl

ude

sele

ctio

n bi

ases

due

to th

ere

tros

pect

ive

natu

re o

f the

stu

dy, t

heus

e of

onl

y on

e ra

diol

ogis

t for

the

iden

tific

atio

n of

fals

e ne

gativ

e re

sults

and

the

low

num

ber

of b

reas

t can

cers

.


www.icsi.org

��

Conclusion Grading Worksheet A – Diagnosis of Breast Disease Annotation #58 (Magnetic Resonance Imaging) Twelfth Edition/January 2008

Aut

hor/

Year

Des

ign

Type

Cla

ssQ

ual-

ity +,–,ø

Popu

latio

n St

udie

d/Sa

mpl

e Si

zePr

imar

y O

utco

me

Mea

sure

(s)/

Resu

lts (e

.g.,

p-va

lue,

conf

iden

ce in

terv

al, r

elat

ive

risk,

odd

s rat

io,

likel

ihoo

d ra

tio, n

umbe

r nee

ded

to tr

eat)

Aut

hors

' Con

clus

ions

/W

ork

Gro

up's

Com

men

ts (i

talic

ized

)

Krie

ge e

t al.,

2004

Sens

itivi

tyan

dsp

ecifi

city

of a

dign

ostic

test

C +

-- 19

09 w

omen

with

acu

mul

ativ

e lif

etim

e ris

k of

brea

st ca

ncer

of 1

5% o

r mor

ean

d an

age

of 2

5 to

70

year

s(m

ean

age

= 40

) wer

e in

clud

edin

mul

ticen

ter s

tudy

in th

eN

ethe

rland

s. W

omen

with

ahi

stor

y of

bre

ast c

ance

r wer

eex

clud

ed.

-- W

omen

wer

e sc

reen

ed e

very

six

mon

ths w

ith a

clin

ical

bre

ast

exam

inat

ion

(CBE

) and

onc

e pe

rye

ar b

y bo

th m

amm

ogra

phy

and

MRI

, with

inde

pend

ent

read

ings

.--

Can

cers

det

ecte

d in

the

scre

enin

g gr

oup

wer

e co

mpa

red

with

thos

e de

tect

ed in

two

age-

sex

mat

ched

cont

rol g

roup

s (on

eof

whi

ch co

nsis

ted

of w

omen

ina

data

base

of b

reas

t can

cers

, and

the

othe

r con

trol

gro

upco

nsis

ting

of a

pop

ulat

ion

with

char

acte

ristic

s sim

ilar t

o th

ein

vest

igat

iona

l pop

ulat

ion

but

with

out u

nder

goin

g th

esc

reen

ing

prot

ocol

)--

Med

ian

follo

w-u

p of

2.9

yea

rs--

358

wom

en w

ere

carr

iers

of

germ

-line

mut

atio

ns.

-- --

Biop

sy u

sed

as fi

nal

diag

nosi

s

-- 51

tum

ors w

ere

dete

cted

(44

inva

sive

canc

ers,

6du

ctal

carc

inom

as in

situ

, and

1 ly

mph

oma)

dur

ing

the

follo

w-u

p pe

riod.

-- Th

e fo

llow

ing

sum

mar

izes

the

rela

tive

effic

acy

ofth

e va

rious

mod

aliti

es in

det

ectin

g in

vasi

ve ca

ncer

.

S

ensi

tivity

Spec

ifici

tyC

BE

1

7.9%

98

.1%

Mam

mog

raph

y

33.

3%

95.0

%M

RI

7

9.5%

89

.8%

Whe

n a

BI-R

AD

S™ sc

ore

of 3

or h

ighe

r was

use

d as

a di

scrim

inat

or, s

ensi

tivity

of C

BE, m

amm

ogra

phy,

and

MRI

scan

ning

wer

e 17

.8%

, 40.

0% a

nd 7

1.1%

;PP

V w

as 9

.6%

, 8.0

% a

nd 7

.1%

, res

pect

ivel

y.

45 ca

ncer

s wer

e ev

alua

ted

for c

ompa

ring

the

met

hods

incl

udin

g 4

inte

rval

canc

ers d

etec

ted

betw

een

two

scre

enin

g ex

ams (

5 br

east

canc

ers w

ere

excl

uded

for v

ario

us re

ason

s as w

as th

e ly

mph

oma)

-- 32

bre

ast c

ance

rs w

ere

dete

cted

on

MRI

(22

ofth

ese

wer

e no

t vis

ible

on

mam

mog

raph

y).

Mam

mog

raph

y de

tect

ed 1

8 tu

mor

s and

mis

sed

27tu

mor

s--

MRI

mis

sed

13 b

reas

t can

cers

(8 o

f the

13

wer

evi

sibl

e on

mam

mog

raph

y, in

clud

ing

5 D

CIS

). 4

of

the

unde

tect

ed tu

mor

s wer

e in

terv

al ca

ncer

s, an

d 1

was

det

ecta

ble

only

on

CBE

.--

The

AU

C fo

r mam

mog

raph

y w

as 0

.686

and

the

AU

C fo

r MRI

was

0.8

27 (d

iffer

ence

bet

wee

n gr

oups

was

sign

ifica

nt a

t p <

0.0

5)--

Non

e of

the

50 p

atie

nts w

ith b

reas

t Ca

died

prio

rto

the

end

of th

e st

udy

perio

d (m

edia

n f/

u =

1.5

yrs)

-- A

utho

rs c

oncl

ude

that

the

sens

itivi

tyof

MRI

was

hig

her t

han

that

for

mam

mog

raph

y al

thou

gh th

e sp

ecifi

city

and

PPV

wer

e lo

wer

.

-- D

iffer

ence

s in

sen

sitiv

ity b

etw

een

MRI

and

mam

mog

raph

y w

as la

rger

whe

n on

ly in

vasi

ve c

ance

rs w

ere

incl

uded

.--

Tum

ors

in th

e st

udy

grou

p w

ere

sign

ifica

ntly

sm

alle

r an

d le

ss li

kely

toha

ve ly

mph

nod

e in

volv

emen

t tha

nth

ose

in th

e tw

o co

ntro

l gro

ups.

-- A

utho

rs c

oncl

uded

that

MRI

scre

enin

g ov

eral

l con

trib

uted

to th

eea

rly d

etec

tion

of h

ered

itary

bre

ast

canc

er, a

lthou

gh it

has

a lo

wer

spec

ifici

ty th

an m

amm

ogra

phy

lead

ing

to th

e ge

nera

tion

of m

ore

“unc

erta

in”

findi

ngs

requ

iring

sho

rt-te

rm fo

llow

-up

or a

dditi

onal

test

ing/

inve

stig

atio

ns.


www.icsi.org

��


Aut

hor/

Year

Des

ign

Type

Cla

ssQ

ual-

ity +,–,

ø

Popu

latio

n St

udie

d/Sa

mpl

e Si

zePr

imar

y O

utco

me

Mea

sure

(s)/

Resu

lts (e

.g.,

p-va

lue,

conf

iden

ce in

terv

al, r

elat

ive

risk,

odd

s rat

io,

likel

ihoo

d ra

tio, n

umbe

r nee

ded

to tr

eat)

Aut

hors

' Con

clus

ions

/W

ork

Gro

up's

Com

men

ts (i

talic

ized

)

War

ner e

t al.,

2004

Sens

/spe

cof di

agno

stic

test

C

+--S

urve

illan

ce st

udy

of 2

36C

anad

ian

wom

en a

ged

25 to

65

year

s (m

ean

age

46.6

) and

who

have

a B

RCA

1 or

BRC

A2

mut

atio

n.--

Excl

usio

ns in

clud

ed p

ts w

ithhi

stor

y of

bila

tera

l bre

ast C

a, p

tsw

ho a

re cu

rren

tly re

ceiv

ing

chem

othe

rapy

, or w

ho w

ere

know

n to

hav

e m

etas

tatic

dise

ase.

-- Pt

s und

erw

ent 1

to 3

scre

enin

gex

amin

atio

ns w

ith M

RI,

mam

mog

raph

y an

d ul

tras

ound

.C

BE w

as p

erfo

rmed

at 6

-mon

thin

terv

als.

-- BI

-RA

DS™

scal

es w

ere

used

to sc

ore

resu

lts fr

omm

amm

ogra

phy

and

MRI

.--

All

part

icip

ants

wer

e fo

llow

edup

for o

ne y

ear a

fter l

ast

scre

enin

g te

st a

nd a

ll ne

wca

ncer

s and

pro

phyl

actic

mas

tect

omie

s wer

e no

ted.

-- Bi

opsy

use

d as

fina

l dia

gnos

ticre

sult

(all

lesi

ons w

ith a

scor

e of

4 or

5 w

ere

biop

sied

)

-- 10

0% o

f wom

en co

mpl

eted

at l

east

1 sc

reen

ing

epis

ode,

58%

com

plet

ed a

t lea

st 2

epi

sode

s, an

d 36

%co

mpl

eted

3 e

piso

des.

120

wom

en w

ere

still

unde

rgoi

ng sc

reen

ing

at th

e tim

e of

this

writ

ing.

-- 31

wom

en le

ft pr

ior t

o fin

ishi

ng a

ll 3

roun

ds.

-- 22

canc

ers w

ere

foun

d (1

6 in

vasi

ve, 6

DC

IS) i

n 21

wom

en.

9.1%

wer

e de

tect

ed b

y C

BE, 3

6% w

ere

dete

ctab

le b

y m

amm

ogra

phy,

33%

by

ultr

asou

ndan

d 77

% b

y M

RI.

MRI

was

sign

ifica

ntly

mor

ese

nsiti

ve th

an e

ither

of t

he o

ther

imag

ing

mod

aliti

es(p

= 0

.02

vs. m

amm

ogra

phy;

p =

0.0

06 v

s.ul

tras

ound

).--

Spec

ifici

ties w

ere

95.4

% fo

r MRI

, 99.

8% fo

rm

amm

ogra

phy,

96%

for u

ltras

ound

and

99.

3% fo

rC

BE.

-- O

nly

one

inte

rval

canc

er fo

und

(bet

wee

n sc

reen

s)--

All

four

scre

enin

g m

odal

ities

had

a co

mbi

ned

sens

itivi

ty o

f 95%

; mam

mog

raph

y an

d C

BE h

ad a

sens

itivi

ty o

f 45%

whe

n co

mbi

ned;

CBE

,m

amm

ogra

phy

and

MRI

com

bine

d ha

d a

sens

itivi

tyof

86%

; th

e se

nsiti

vity

of a

ll im

agin

g m

odal

ities

othe

r tha

n M

RI w

as 6

4%;

-- 32

% o

f can

cers

wer

e de

tect

ed o

n M

RI b

ut m

isse

dby

oth

er im

agin

g m

etho

ds; 2

canc

ers w

ere

foun

d by

mam

mog

raph

y al

one,

with

2 m

ore

canc

ers d

etec

ted

by u

ltras

ound

alo

ne; M

RI d

etec

ted

75%

of c

ance

rsm

isse

d by

mam

mog

raph

y an

d C

BE (i

.e.,

conv

entio

nal s

urve

illan

ce)

-- A

ll 22

pts

with

Ca

are

curr

ently

dis

ease

-free

.--

AU

C:

0.89

for M

RI, 0

.77

for m

amm

ogra

phy,

0.6

5fo

r ultr

asou

nd, 0

.48

for C

BE, 0

.93

for a

ll 4

mod

aliti

es,

0.94

for C

BE, m

amm

ogra

phy

and

MRI

, and

0.7

7 fo

rm

amm

ogra

phy

and

CBE

.

-- A

dditi

on o

f ann

ual M

RI a

ndul

tras

ound

to m

amm

ogra

phy

and

CBE

sign

ifica

ntly

impr

oves

the

sens

itivi

ty o

fsu

rvei

llanc

e fo

r ear

ly d

etec

tion

of b

reas

tca

ncer

s, al

thou

gh a

ddin

g ul

tras

ound

may

incr

ease

fals

e-po

sitiv

e ra

te.

--

Hig

h br

east

den

sity

in y

oung

erw

omen

mak

es m

amm

ogra

phy

alon

ele

ss u

sefu

l.--

Nee

ds fu

rthe

r inv

estig

atio

n to

sho

wth

at su

ch s

urve

illan

ce in

this

pop

ulat

ion

low

ers b

reas

t can

cer

mor

talit

y.


www.icsi.org

�8


Aut

hor/

Year

Des

ign

Type

Cla

ssQ

ual-

ity +,–,

ø

Popu

latio

n St

udie

d/Sa

mpl

e Si

zePr

imar

y O

utco

me

Mea

sure

(s)/

Resu

lts (e

.g.,

p-va

lue,

conf

iden

ce in

terv

al, r

elat

ive

risk,

odd

s rat

io,

likel

ihoo

d ra

tio, n

umbe

r nee

ded

to tr

eat)

Aut

hors

' Con

clus

ions

/W

ork

Gro

up's

Com

men

ts (i

talic

ized

)

MA

RIBS

Stud

y G

roup

,20

05

Sens

/spe

cof di

agno

stic

test

C

ø--

Part

of t

he M

agne

ticRe

sona

nce

Imag

ing

Brea

stSc

reen

ing

(MA

RIBS

) stu

dy--

Mul

ticen

ter s

tudy

in 6

49w

omen

age

d 35

-49

year

s (m

ean

age

of 4

0) w

ith a

stro

ng fa

mily

hist

ory

of b

reas

t can

cer a

nd/o

rw

ith a

hig

h pr

obab

ility

of

BRC

A1,

BRC

A2

or T

P53

mut

atio

n.--

All

part

icip

ants

wer

e of

fere

dan

nual

scre

enin

g w

ithm

amm

ogra

phy

and

cont

rast

-en

hanc

ed M

RI fo

r 2 to

7 y

ears

.--

Excl

usio

ns in

clud

ed p

ts w

ithpr

evio

us h

isto

ry o

f bre

ast C

a or

who

hav

e an

y ot

her c

ance

r for

whi

ch th

e pr

ogno

sis (

life-

expe

ctan

cy) w

as le

ss th

an 5

year

s.--

To m

easu

re se

nsiti

vity

and

spec

ifici

ty, B

I-RA

DS

scor

es o

f 0,

3, 4

, 5 w

ere

cons

ider

ed to

be

posi

tive

outc

omes

.--

Biop

sy u

sed

as fi

nal d

iagn

ostic

resu

lt.

-- 30

wom

en w

ithdr

ew fr

om st

udy

sinc

e be

cam

ein

elig

ible

for f

urth

er w

orku

p (a

ccou

ntin

g fo

r mos

t of

drop

out r

ate)

.--

6 ca

ncer

s wer

e de

tect

ed b

y m

amm

ogra

phy

only

,19

by

MRI

onl

y, a

nd 8

onl

y by

bot

h m

odal

ities

, with

2 in

terv

al ca

ses (

tota

l of 3

5 ca

ncer

s).

-- Se

nsiti

vitie

s wer

e 77

%, 4

0% a

nd 9

4% fo

r MRI

,m

amm

ogra

phy

and

both

mod

aliti

es, r

espe

ctiv

ely.

Sens

itivi

ty w

as si

gnifi

cant

ly h

ighe

r for

MRI

than

for

mam

mog

raph

y (p

= 0

.01)

; sen

sitiv

ities

for

mam

mog

raph

y an

d M

RI h

ad th

e la

rges

t diff

eren

cefo

r BRC

A1

mut

atio

n ca

rrie

rs (p

= 0

.004

).--

Spec

ifici

ties w

ere

81%

, 93%

and

77%

for M

RI,

mam

mog

raph

y an

d bo

th m

odal

ities

, res

pect

ivel

y.--

PPV

s wer

e 7.

3% a

nd 1

0% fo

r MRI

and

mam

mog

raph

y, re

spec

tivel

y, w

here

as th

e N

PV w

as99

% fo

r mam

mog

raph

y an

d 99

% fo

r MRI

-- A

UC

: 0.

85 fo

r MRI

, 0.7

0 fo

r mam

mog

raph

y (p

=0.

035

for d

iffer

ence

)--

Can

cer d

etec

tion

rate

s wer

e 26

.9 p

er 1

000

wom

an-

year

s on

initi

al e

xam

inat

ion

(pre

vale

nce)

and

12.

8pe

r 100

0 w

oman

yea

rs o

n su

bseq

uent

test

ing

(inci

denc

e)--

Usi

ng o

nly

the

prev

alen

ce te

sts (

20 ca

ncer

s),

sens

itivi

ties w

ere

75%

and

40%

for M

RI a

ndm

amm

ogra

phy,

resp

ectiv

ely

(p =

0.1

2 fo

r diff

eren

ce),

alon

g w

ith sp

ecifi

citie

s of

82%

and

93%

for M

RI a

ndm

amm

ogra

phy,

resp

ectiv

ely

( (p

< 0.

0001

).

-- In

wom

en a

t hig

h ris

k fo

r bre

ast

canc

er b

ased

on

fam

ily h

isto

ry,

scre

enin

g w

ith M

RI is

mor

e se

nsiti

vebu

t les

s sp

ecifi

c th

an m

amm

ogra

phy.

Thro

ugh

com

bini

ng b

oth

mod

aliti

es,

sens

itivi

ty in

crea

ses

alth

ough

ther

e is

afu

rthe

r dec

line

in sp

ecifi

city

.

-- N

eed

asse

ssm

ent o

f effe

ct o

fsc

reen

ing

exam

s on

mor

talit

y.--

Attr

ition

rat

e lo

w.


www.icsi.org

��


Aut

hor/

Year

Des

ign

Type

Cla

ssQ

ual-

ity +,–,

ø

Popu

latio

n St

udie

d/Sa

mpl

e Si

zePr

imar

y O

utco

me

Mea

sure

(s)/

Resu

lts (e

.g.,

p-va

lue,

conf

iden

ce in

terv

al, r

elat

ive

risk,

odd

s rat

io,

likel

ihoo

d ra

tio, n

umbe

r nee

ded

to tr

eat)

Aut

hors

' Con

clus

ions

/W

ork

Gro

up's

Com

men

ts (i

talic

ized

)

Lehm

an e

t al.,

2005

Sens

/spe

cof

adi

agno

stic

test

C

ø--

Mul

ticen

ter s

tudy

ana

lyzi

ngre

sults

from

367

asy

mpt

omat

icw

omen

with

a li

fetim

e ris

k of

brea

st ca

ncer

of g

reat

er th

an25

% b

ased

on

fam

ily h

isto

ry o

rge

netic

test

ing.

Sub

ject

s als

one

eded

to b

e 25

yea

rs o

f age

or

over

.--

Wom

en p

rese

ntin

g w

ithpa

lpab

le b

reas

t les

ions

and

/or

mam

mog

raph

ic a

bnor

mal

ities

prio

r to

asse

ssm

ent w

ere

not

elig

ible

.--

All

patie

nts r

ecei

ved

a C

BE,

mam

mog

raph

y an

d M

RI sc

an a

spa

rt o

f the

stud

y.--

Read

ers o

f MRI

and

mam

mog

raph

y re

sults

wer

ebl

ind

to th

e re

sults

of t

he o

ther

mod

ality

.--

All

lesi

ons w

ith a

BI-R

AD

S™sc

ore

of 4

or 5

on

eith

er m

odal

ityw

ere

reco

mm

ende

d fo

r bio

psy.

-- 38

bio

psie

s wer

e re

com

men

ded

base

d on

imag

ing

resu

lts;

27 b

iops

ies w

ere

perf

orm

ed le

adin

g to

adi

agno

sis o

f 4 ca

ncer

s (1.

1% ca

ncer

yie

ld).

-- Bi

opsy

reco

mm

enda

tion

rate

for M

RI w

as 8

.5%

and

the

rate

for m

amm

ogra

phy

was

2.2

%.

-- 11

lesi

ons r

ecom

men

ded

for b

iops

y di

d no

tun

derg

o bi

opsy

for v

ario

us re

ason

s (e.

g. cy

stic

lesi

ons,

patie

nt p

refe

renc

e)--

All

4 ca

ncer

s wer

e fo

und

on M

RI; m

amm

ogra

phy

dete

cted

onl

y 1

canc

er, a

lthou

gh a

dditi

onal

canc

eryi

eld

for M

RI w

as n

ot si

gnifi

cant

ly d

iffer

ent f

rom

mam

mog

raph

y (li

kely

due

to th

e sm

all n

umbe

r of

canc

ers)

-- M

RI re

sulte

d in

20

fals

e po

sitiv

es; m

amm

ogra

phy

resu

lted

in 3

fals

e-po

sitiv

e fin

ding

s--

All

wom

en w

ere

node

-neg

ativ

e w

ithou

t met

asta

ticdi

seas

e.

-- Th

ere

is a

hig

her f

alse

-pos

itive

rat

efo

r MRI

than

for m

amm

ogra

phy

-- A

utho

rs s

tate

that

lim

itatio

ns to

the

stud

y in

clud

e no

long

-term

follo

w-u

pto

iden

tify

fals

e ne

gativ

e re

sults

, the

fact

that

onl

y a

sing

le ro

und

ofsc

reen

ing

was

pro

vide

d, la

ck o

fde

taile

d in

form

atio

n on

prio

r scr

eeni

nghi

stor

ies.

-- M

RI n

ot r

ecom

men

ded

as a

repl

acem

ent f

or m

amm

ogra

phy

but a

s a

com

plem

ent.

A n

egat

ive

MRI

sho

uld

not o

verr

ule

the

use

of b

iops

y ba

sed

ona

susp

icio

us m

amm

ogra

m.

-- Ri

sk o

f hav

ing

a be

nign

bio

psy

was

abou

t 5%

ove

rall

in h

igh-

risk

wom

en.

�0


Support for Implementation:


Copyright © 2008 by Institute for Clinical Systems Improvement

This section provides resources, strategies and measurement specifications for use in closing the gap between current clinical practice and the recommendations set forth in the guideline.

The subdivisions of this section are:

• Priority Aims and Suggested Measures

- Measurement Specifications

• Key Implementation Recommendations

• Knowledge Resources

• Resources Available


www.icsi.org

�1

Priority Aims and Suggested Measures

1. Reduce the length of time between first knowledge of a breast abnormality and diagnostic resolution.

Possible measures for accomplishing this aim:

a. Average number of days between patient phone call about breast abnormality and RN or MD visit.

b. Average number of days between a breast abnormality noted by RN or MD and a diagnostic workup to be maximum of 7-10.

c. Percentage of class 4 or class 5 abnormal mammograms that are followed by a biopsy within 7-10 days.

d. Average number of days between pathology report and documentation that patient was informed of results.

The ultimate goal is to decrease the time from identification of a breast abnormality to notification of the patient of biopsy results.

2. Ensure that a bloody tap or a persistent mass following aspiration of a palpable dominant mass is referred to a surgeon or radiologist regardless of negative imaging.

Possible measures for accomplishing this aim:

a. Percentage of patients with bloody tap following aspiration of a palpable dominant mass who are referred to a surgeon or radiologist regardless of a negative mammogram or ultrasound.

b. Percentage of patients with residual mass following aspiration of a palpable dominant mass who are referred to a surgeon or radiologist regardless of a negative mammogram or ultrasound.

3. Ensure that patients with spontaneous bloody or watery discharge have a mammogram (with or without an ultrasound) and are referred to a surgeon or radiologist.

Possible measure for accomplishing this aim:

a. Percentage of patients with spontaneous bloody or watery discharge who have a mammogram (with or without an ultrasound) and are referred to a surgeon or radiologist.

4. Ensure that needle biopsies demonstrating abnormal pathologic findings are followed by performance of an open biopsy.


a. Percentage of patients with a diagnosis of abnormal pathologic findings (lobular neoplasia, ductal hyperplasia with atypia, phylloides tumor lobular carcinoma insitu [LCIS] or papillary lesions) on needle biopsy who subsequently have an open biopsy performed.

5. Ensure that all women with breast concern that is indeterminate or vague will have short-term follow-up clinical assessment.


a. Percentage of women with an indeterminate breast concern who have a follow-up clinical exam within two months.



www.icsi.org

�2

Measurement Specifications

Possible Success Measure #1cPercentage of class 4 or class 5 abnormal mammograms that are followed by a biopsy within 7-10 days.

Population DefinitionWomen through age 74 with biopsy for possible diagnosis of breast cancer.

Data of InterestPercentage of class 4 or class 5 abnormal mammograms that are followed by a biopsy within 7-10 days.

Numerator/Denominator DefinitionsNumerator: Total # of patients with less than 10 days between the first documentation of a

mammogram abnormality and a completed biopsy for all records reviewed.

Denominator: Total # of patients with an abnormal mammogram undergoing biopsy.

Method/Source of Data CollectionA list of all patients with breast biopsies for mammogram abnormalities during the previous target period. The medical records can be reviewed to determine the number of days between first documentation of an abnormal mammogram and completion of a biopsy.

Time Frame Pertaining to Data CollectionData may be collected semiannually.

NotesThe intent of this measure is to determine the time interval involved and provide a sense of the extent of "sleepless nights" for the patient.

Diagnosis of Breast Disease Priority Aims and Suggested Measures Twelfth Edition/January 2008


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Key Implementation Recommendations

1. Primary Care, Radiology and Surgery:

Establish a communication plan to include all providers involved in the patient's treatment plan:

• Patients undergoing biopsy should have results reported to the radiologist and/or surgeon performing the procedure, as well as the primary care provider.

2. Primary Care:

Establish a system for education of all female patients regarding self breast examination and age-appro-priate mammographic screening intervals.

Develop a system for timely assessment of palpable breast masses including necessary imaging studies, follow-up, and referral to radiology or surgery for biopsy.

3. Radiology:

Establish a process that ensures that abnormalities of the breast are accurately identified and sorted, and that all appropriate radiologic imaging studies necessary to the evaluation process are efficiently completed.

4. Surgery:

Establish a process for timely completion of evaluation of breast lesions and provide additional surgical breast consultation as needed.

5. Documentation:

Develop a system to document time frame from receipt of pathology to patient information.

• Telephone call documentation



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Knowledge Resources

Criteria for Selecting ResourcesThe following resources were selected by the Diagnosis of Breast Disease guideline work group as addi-tional resources for providers and/or patients. The following criteria were considered in selecting these resources.

• The site contains information specific to the topic of the guideline.

• The content is supported by evidence-based research.

• The content includes the source/author and contact information.

• The content clearly states revision dates or the date the information was published.

• The content is clear about potential biases, noting conflict of interest and/or disclaimers as appropriate.

Resources Available to ICSI Members OnlyICSI has a wide variety of knowledge resources that are only available to ICSI members (these are indicated with an asterisk in far left-hand column of the Resources Available table). In addition to the resources listed in the table, ICSI members have access to a broad range of materials including tool kits on CQI processes and Rapid Cycling that can be helpful. To obtain copies of these or other Knowledge Resources, go to http://www.icsi.org/knowledge. To access these materials on the Web site you must be logged in as an ICSI member.

The Knowledge Resources list in the table on the next page that are not reserved for ICSI members are available to the public free-of-charge.



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* Title/Description Audience Author/Organization Web Sites/Order InformationWeb site is rich in information about breast cancer risk factors, screening and treatment. Diagrams assist with understanding of breast anatomy and surgery. By calling organization, this educational information can be ordered:-For Women Facing Breast Cancer (booklet, #4652.00)-For Women Facing a Breast Biopsy (English or Spanish)-ABCs of Breast Health-A Personal Plan of Action (#3416.01)-The Older You Get, the More You Need a Mammogram (#5020.00)-Guidelines for the Early Detection of Cancer (#2070.00)-Breast Health (#2048.00, available in multiple languages)-Cancer Facts for Women (#2007.00, Spanish available)-After Diagnosis: A Guide for Patients and Families (#9440.00)

Public American Cancer Society

http://www.cancer.org/

Phone#: 800-ACS-2345

Information/support includes online chats specifically for women under age 45, women with metastatic breast can-cer, and those with general questions. Transcripts of educational teleconfer-ences about the latest information in breast cancer. Links to reputable sites.

Public Living Beyond Breast Cancer

http://www.lbbc.org

The Condition Center on Breast Cancer Web site provides informa-tion on frequently asked questions. A search on breast disease yields multiple topics. Women may e-mail questions to Mayo physicians.

Public Mayo Clinic http://www.mayoclinic.com

Calender of conferences, as well as data from clinical trials. Information on choosing support groups. E-mail reminders of breast exam available.

Public;Health Care Professionals

National Alliance of Breast Cancer Organizations (NABCO)

http://www.nabco.org

Resources Available

* Available to ICSI members only.



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* Title/Description Audience Author/Organization Web Sites/Order InformationThe latest information on cancer treat-ment at both the professional and lay public level, the latest cancer research news, and clinical trial information. Cancer information hotline and ability to search cancer scientific literature. All NCI publications are available online. Additionally, calling NCI can obtain:• What You Need to Know About Breast Cancer (booklet)• Mammograms: Not Just Once but for a Lifetime (booklet)

Public National Cancer Institute

http://www.cancer.gov1-800-4-CANCER

Advocacy and support information for special populations with breast cancer. Glossary of terms. Recent relevant breast cancer news items. Educational literature available to order through Web site includes:-Breast Health – Learn the FactsBy calling organization can order:-Breast Self-Exam Shower Card (English & Spanish)

Public Susan G. Komen Breast Cancer Foundation

http://www.komen.org1-800-462-9273

Access available in English or Spanish. 24-hour toll-free hotline. Information on male breast cancer and advocacy. Infor-mation for partners supporting women with breast cancer. Men's match program to support male partners of women with breast cancer through trained phone volunteers.

Public Y-Me National Breast Cancer Organization

http://www.y-me.org

This educational literature can be ordered from Web site: - Breast Biopsy - Stereotactic Breast Biopsy

Women Krames Experts in Patient Education

http://www.krames.com

Information from health library index includes topics related to breast disease, cancer and breast self-exam.

Women HealthEast Care System

http://www.healtheast.org

Things to Know About Quality Mammograms

Women Agency for Health Care Policy & Research (AHRQ)

http://www.ahrq.gov800-358-9295

Diagnosis of Breast Disease Resources Available Twelfth Edition/January 2008



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* Title/Description Audience Author/Organization Web Sites/Order InformationWeb site includes recent articles about breast disease published in the journal of the academy.

Women American Academy of Family Physicians

http://www.aafp.org1-800-274-2237

Detecting and Treating Breast Lumps Early

Women American College OB/GYN

http://www.acog.org

Mammography and Breast Cancer Screening (brochure)

Women Park Nicollet Health Services

http://www.icsi.org Search: mammography

Diagnosis of Breast Disease Resources Available Twelfth Edition/January 2008
