• University of Michigan Health System. Common breast problems. Ann Arbor (MI): University of Michigan Health System; 2007 Oct. 10 p. [7 references]

This is the current release of the guideline.

Common breast problems:

• Palpable mass or asymmetry
• Breast pain with negative exam
• Nipple discharge without abnormal exam findings
• Risk for breast cancer

Diagnosis
Evaluation
Management
Risk Assessment
Screening
Treatment

Family Practice
Internal Medicine
Obstetrics and Gynecology

Advanced Practice Nurses
Nurses
Physician Assistants
Physicians

• To identify appropriate evaluation and management strategies for women who present with four common breast problems
• Identify appropriate indications for referral to a breast specialist

Adults age 18 and older (non-pregnant)

Diagnosis/Evaluation/Risk Assessment/Screening

1. Inspection and palpation with clinical breast exam (CBE)
2. Mammography
3. Ultrasound
4. Adjunctive magnetic resonance imaging (MRI)
5. Fine needle aspirate (FNA) with or without fluid cytology, as appropriate
6. Risk assessment using the National Cancer Institute's (NCI's) Breast Cancer Risk Assessment Tool
7. Referral to a breast specialist

Management/Treatment

1. Nonpharmacologic interventions to reduce breast pain, such as a well fitting bra, relaxation techniques, warm compresses or cold packs, gentle massage and a diet low in fat
2. Changes in current dose or in current medication
3. Pharmacologic treatment for breast pain including evening of primrose oil, diclofenac gel, non-steroidal anti-inflammatory drugs (NSAIDs), and hormonally active medicines including progesterone, Danazol, and Bromocriptine
4. Management of women at high risk for breast cancer including:
   • Counseling
   • Risk reduction therapy including Tamoxifen, Raloxifene, and Tamosifen
   • Referral to specialist to discuss genetic testing, as well as surgical options such as prophylactic mastectomy or oophorectome or participation in risk reduction trial

• Positive predictive value, sensitivity and/or specificity of diagnostic tests
• Incidence of breast cancer

Hand-searches of Published Literature (Primary Sources)
Searches of Electronic Databases

The literature searches for this update began with the results of the literature searches performed for the earlier version of this guideline through June 2000. For this update the Breast Cancer Screening and Diagnosis Guidelines of the National Comprehensive Cancer Network (2004) and its supporting literature through early 2004 were used to address the topics of nipple discharge, palpable mass, and screening of high risk women. The topics of breast pain and galactorrhea were used as major key words in separate MEDLINE searches of literature published from 1/1/99 through 5/31/05 in English for adult women with additional key words of guidelines and controlled trials.

The searches were supplemented with recent clinical trials known to expert members of the panel. The search was single cycle.

Not stated

Weighting According to a Rating Scheme (Scheme Given)

Levels of Evidence

1. Randomized controlled trials
2. Controlled trials, no randomization
3. Observational trials
4. Opinion of expert panel

Systematic Review

Conclusions were based on prospective randomized clinical trials if available, to the exclusion of other data. If randomized clinical trials (RTCs) were not available, observational studies were admitted to consideration. If no such data were available, expert opinion was used to estimate effect size.

Expert Consensus

Not stated

Not applicable

A formal cost analysis was not performed and published cost analyses were not reviewed.

Peer Review

The guideline was reviewed at clinical conferences or grand rounds meetings of divisions and departments to which the content is most relevant. This guideline was reviewed at meetings of Family Medicine, General Medicine, Radiology/Breast Imaging, and Surgical Oncology/Breast Care. The revised document is reviewed by the Guidelines Steering Committee, composed of representatives from all primary care specialties. The UMHS Executive Committee on Clinical Affairs performs a final review prior to institutionally endorsing the guideline.

The following clinical algorithms are provided in the original guideline document:

• Palpable Breast Mass or Asymmetry: Diagnosis and Treatment
• Breast Pain Diagnosis and Treatment
• Nipple Discharge Diagnosis and Treatment (no mass)

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations" field).

Conclusions were based on prospective randomized clinical trials (RCTs) if available, to the exclusion of other data. If RCTs were not available, observational studies were admitted to consideration. If no such data were available, expert opinion was used to estimate effect size.

Appropriate evaluation and management strategies for women who present with common breast problems

• Mammography as a diagnostic tool may result in false negatives, especially in younger women. Overall, 10% of diagnostic mammograms are false negatives, with approximately twice the rate for younger women and half that rate for women over age 65.
• While magnetic resonance imaging (MRI) increases sensitivity compared to mammography alone in women at highest risk for breast cancer, it does so at the cost of decreased specificity and an increased need for invasive diagnostic procedures.
• For evaluation of solid masses, or nonpalpable masses detected by mammography, the sensitivity of fine needle aspiration (FNA) is variable, primarily dependent on the skill of the aspirator. Estimates of false negatives range from 1% to 35% for palpable lesions and up to 68% for nonpalpable lesions.
• Side effects of hormonally active medicines tend to limit their tolerability
• Risks and adverse side effects of Tamoxifen include increased incidence of endometrial cancer, deep venous thrombosis, potential increase in cataract formation, and increased liver enzymes. In perimenopausal women, hot flashes generally occur and there is a potential for adverse effect on bone density.
• The risk of lower extremity deep vein thrombosis (DVT) was increased with both Raloxifene and Tamoxifen; stroke risk was equal. The risk of adverse events with both interventions increases with a woman's age.

Absolute contraindications of Tamoxifen and Raloxifne include history of deep venous thrombosis or pulmonary embolism, thrombotic stroke, transient ischemic attacks, or pregnancy/pregnancy potential.

These guidelines should not be construed as including all proper methods of care or excluding other acceptable methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding any specific clinical procedure or treatment must be made by the physician in light of the circumstances presented by the patient.

An implementation strategy was not provided.

Getting Better
Staying Healthy

Effectiveness
Patient-centeredness

• University of Michigan Health System. Common breast problems. Ann Arbor (MI): University of Michigan Health System; 2007 Oct. 10 p. [7 references]

Not applicable: The guideline was not adapted from another source.

2007 Oct

University of Michigan Health System - Academic Institution

University of Michigan Health System

Breast Care Guideline Team

Team Leaders: Amy F. Saunders, MD, General Medicine

Team Members: Amy B. Locke, MD, Family Medicine; R. Van Harrison, PhD, Medical Education; Lisa A. Newman, MD, MPH, General Surgery; Mark D. Pearlman, MD, Obstetrics & Gynecology; Mark A. Helvie, MD, MS, Radiology/Breast Imaging

Guidelines Oversight Team: Connie J. Standiford, MD; William E. Chavey, MD; R. Van Harrison, PhD

The University of Michigan Health System endorses the Guidelines of the Association of American Medical Colleges and the Standards of the Accreditation Council for Continuing Medical Education that the individuals who present educational activities disclose significant relationships with commercial companies whose products or services are discussed. Disclosure of a relationship is not intended to suggest bias in the information presented, but is made to provide readers with information that might be of potential importance to their evaluation of the information.

None of the members of the Breast Problems Guideline Team have relationships with commercial companies whose products are discussed in this guideline. (The members of these teams are listed on the front page of this guideline.)

This is the current release of the guideline.

This NGC summary was completed by ECRI Institute on January 24, 2008. The information was verified by the guideline developer on February 11, 2008.

This NGC summary is based on the original guideline, which is copyrighted by the University of Michigan Health System (UMHS).