Skip Navigation
PrintDownload PDFGet Adobe ReaderDownload to WordDownload as HTMLDownload as XMLCitation Manager
Save to Favorites
Guideline Summary
Guideline Title
Breast cancer screening clinical practice guideline.
Bibliographic Source(s)
Kaiser Permanente Care Management Institute. Breast cancer screening clinical practice guideline. Oakland (CA): Kaiser Permanente Care Management Institute; 2010 Aug. 142 p. [112 references]
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Breast cancer

Guideline Category
Counseling
Diagnosis
Prevention
Risk Assessment
Screening
Clinical Specialty
Family Practice
Internal Medicine
Obstetrics and Gynecology
Oncology
Preventive Medicine
Intended Users
Advanced Practice Nurses
Allied Health Personnel
Managed Care Organizations
Nurses
Physician Assistants
Physicians
Guideline Objective(s)

To assist Kaiser Permanente physicians, administrators, and other health care professionals in determining the most effective medical practices

Target Population

Women 25 years of age and older

Interventions and Practices Considered
  1. Assessment of breast cancer risk factors
  2. Mammography screening
  3. Breast self-examination
  4. Clinical breast examination
  5. Magnetic resonance imaging (MRI) screening
Major Outcomes Considered
  • Morbidity and mortality from breast cancer
  • Measures of breast cancer incidence (relative risk, odds ratios, risk ratios, hazard ratios, etc.)
  • False-positive test leading to unnecessary biopsy, possible treatment and adverse outcomes of treatment, over-diagnosis of breast cancer, identification and treatment of a clinically insignificant (indolent) lesion, unnecessary radiation exposure
  • False-negative test leading to delay in the diagnosis of disease
  • Anxiety
  • Discomfort or pain
  • Cost-effectiveness

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Guidelines are developed with the use of an "evidence-based methodology" and involve a systematic literature search, critical appraisal of the research design and statistical results of relevant studies, and grading of the sufficiency (quantity, quality, consistency, and relevancy) of the evidence for drawing conclusions. An evidence search includes literature published in peer-reviewed scientific journals, existing evidence-based guidelines, consensus-based statements from external professional societies and government health organizations, and clinical expert opinion of Kaiser Permanente regional specialty groups.

For details of the literature search, including databases searched and search terms for each clinical question, see the original guideline document.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Refer to Table 2 in Appendix A of the original guideline document for the Kaiser Permanente system for grading the strength of a body of evidence.

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

The Guidelines Project Management Team performed systematic reviews of the medical literature on each of the clinical questions identified by the workgroup.

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

To develop or revise a guideline, Care Management Institute (CMI) consultants work with a multidisciplinary Guideline Development Team (GDT). Each GDT consists of a core group of physicians, representing primary care and the specialties most affected by the guideline topic, and, as appropriate, other content experts from disciplines such as pharmacy, nursing, and health education. The members of a GDT are nominated by the respective National Guideline Directors to represent their regions. The GDT reviews the appraisal of the evidence and develops or revises clinical recommendations based on the current evidence. Each regional representative then presents the draft guideline recommendations to key experts and champions in their regions for critical review and support to improve the likelihood of implementation once the guideline is published.

To develop the Breast Cancer Screening Guideline, a multidisciplinary, interregional GDT first met in January 2010 to define the scope of the guideline. In 2010, a comprehensive review was conducted (however, only recommendations 2A, 5, and 8 were changed). The Project Management Team then performed systematic reviews of the medical literature on each of the clinical questions identified by the GDT, assembled the evidence, and developed draft recommendations for review by the GDT. All of the recommendations and supporting evidence were reviewed in depth by the GDT in August 2010.

Rating Scheme for the Strength of the Recommendations

Recommendations are classified as either "evidence-based (A-D, I)" or "consensus-based."

Label and Language of Recommendations

Recommendation Label Recommendation Statement* Evidence-Base
Evidence-Based Recommendations
Evidence-Based, A The Guideline Development Team (GDT) strongly recommends the intervention. The intervention improves important health outcomes, based on good evidence, and the GDT concludes that benefits substantially outweigh harms and costs.
Evidence-Based, B The GDT recommends the intervention. The GDT concludes that the intervention improves important health outcomes, based on 1) good evidence that benefits outweigh harms and costs; or 2) fair evidence that benefits substantially outweigh harms and costs.
Evidence-Based, C The GDT makes no recommendation for or against the intervention.† Evidence is sufficient to determine the benefits, harms, and costs of an intervention, and there is at least fair evidence that the intervention improves important health outcomes. But the GDT concludes that the balance of benefits, harms, and costs is too close to justify a general recommendation.
Evidence-Based, D The GDT recommends against the intervention. The GDT finds at least fair evidence that the intervention is ineffective, or that harms or costs outweigh benefits.
Evidence-Based, I The GDT makes no recommendation for or against the intervention.† The GDT concludes that evidence that the intervention is effective is lacking, of poor quality, or conflicting and the balance of benefits, harms, and costs cannot be determined.
Consensus-Based Recommendations
Consensus-Based The GDT recommends the intervention. The recommendation is based on the consensus of the GDT, typically in the setting of insufficient evidence.
Consensus-Based The GDT has determined that the intervention is an option. The recommendation is based on the consensus of the GDT, typically in the setting of insufficient evidence.
Consensus-Based The GDT recommends against the intervention. The recommendation is based on the consensus of the GDT, typically in the setting of insufficient evidence.
Note that most consensus-based recommendations will have evidence grade "Insufficient." For the rare consensus-based recommendations which have "Good" or "Fair" evidence, the evidence must support a different recommendation, because if the evidence were good or fair, the recommendation would usually be evidence-based. In this kind of consensus-based recommendation the evidence label should point this out, e.g., "Good, supporting a different recommendation."

*All statements specify the population for which the recommendation is intended.

†At the discretion of the GDT, the recommendation may use the language, "option," but must list all the equivalent options.

Cost Analysis

The guideline reviewers reviewed published cost analyses.

Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation

The Guideline Quality Committee reviewed and approved the guideline in August 2010. The guideline was approved by the National Guideline Directors in August 2010.

Recommendations

Major Recommendations

Recommendations are identified as either "evidence-based (A-D, I)" or "consensus-based." For definitions of the levels of recommendations see the end of the "Major Recommendations" field.

Breast Cancer Risk Factors

Asymptomatic women are considered to be at high risk of breast cancer if they have one or more of the following risk factors:

1.A. Personal history of breast cancer (including ductal carcinoma in situ). Consensus-based

1.B. Breast biopsy showing atypical hyperplasia or lobular neoplasia (lobular carcinoma in situ). Evidence-based: B*

1.C. First-degree relative diagnosed with breast cancer. Evidence-based: B

1.D. Women who have been tested and found to have a clinically significant alteration in a BRCA gene associated with increased risk for the development of breast cancer, or who have a first-degree relative who has been tested and found to have such an alteration, or a first or second degree relative with early-onset (diagnosis before age 50) breast cancer and/or ovarian cancer (at any age). Consensus-based

1.E. Prior chest radiation therapy. Consensus-based

*See Appendix A for more detail regarding evidence grading.

First-degree relative = parent, sibling, or child; second-degree relative = aunt, uncle, grandparent, niece, nephew, or half sibling

Mammography Screening in Asymptomatic Women without Breast Cancer Risk Factors

2.A. Routine mammography screening is recommended for asymptomatic women aged 50 to 74. Evidence-based: B

2.B. For women aged 75 and older, offer mammography in the context of a shared decision-making approach, taking into consideration life expectancy, patient preference, existing comorbidities, and clinician judgment. Consensus-based

2.C. For women under age 40, routine mammography screening is not recommended. Consensus-based

2.D. For women aged 40 to 49, offer mammography in the context of a shared decision-making approach, taking into consideration life expectancy, patient preference, existing comorbidities, and clinician judgment. Consensus-based

2.E. The screening frequency for mammography is every one to two years. Consensus-based

Mammography Screening in Asymptomatic Women with Selected Breast Cancer Risk Factors

3.A. Mammography screening is recommended for women with one or more of the following selected risk factors for breast cancer:

Risk Factor Begin Screening
  • Personal history of breast cancer (including ductal carcinoma in situ)
  • At age of diagnosis
  • Breast biopsy showing atypical hyperplasia or lobular neoplasia (lobular carcinoma in situ)
  • At age of diagnosis
  • First-degree relative* diagnosed with breast cancer
  • Five to ten years earlier than the affected family member's age at diagnosis, or by age 40.
Genetic Risk  
  • Clinically significant alteration in a BRCA1 or BRCA2 gene in the patient or a first-degree relative, or
  • Family history of breast cancer in a first- or second-degree relative (diagnosed before the age of 50) and/or ovarian cancer (diagnosed at any age)
  • The year the alteration was found in the patient or five to ten years earlier than the affected family member's age at diagnosis (but not before age 25), taking into consideration individual circumstances and patient preferences.
  • Prior chest radiation therapy
  • At age 25

Consensus-based

*First-degree relative = parent, sibling, or child; second-degree relative = aunt, uncle, grandparent, niece, nephew, or half sibling)

3.B. For women with risk factors for breast cancer, annual mammography screening is recommended. Consensus-based

Breast Self-Examination (BSE)

4.A. Inform women of the lack of benefit and the potential harms of BSE. A shared decision-making approach that takes into account a woman's personal preferences and the balance of benefit to harm is recommended. Consensus-based

4.B. Counsel all women to seek immediate medical attention upon detection of a breast lump. Consensus-based

Clinical Breast Examination (CBE) for Asymptomatic Women without Breast Cancer Risk Factors

5. Offer CBE to asymptomatic women without breast cancer risk factors, in the context of a shared decision-making approach that takes into account a woman's personal preferences and the balance of benefit to harm. Consensus-based

*CBE is not a prerequisite to obtaining a mammogram. The sensitivity of mammography in the general population is limited (71% to 96%), and CBE may detect additional breast cancers. The sensitivity of CBE ranges from 40% to 69%.

CBE for Asymptomatic Women with Selected Breast Cancer Risk Factors

6. CBE is recommended for women with the following selected risk factors for breast cancer:

Risk Factor Begin Screening
  • Personal history of breast cancer (including ductal carcinoma in situ)
  • At age of diagnosis
  • Breast biopsy showing atypical hyperplasia or lobular neoplasia (lobular carcinoma in situ)
  • At age of diagnosis
  • First-degree relative* diagnosed with breast cancer
  • Five to ten years earlier than the affected family member's age at diagnosis, or by age 40.
Genetic Risk  
  • Clinically significant alteration in a BRCA1 or BRCA2 gene in the patient or a first-degree relative, or
  • Family history of breast cancer in a first- or second-degree relative (diagnosed before the age of 50) and/or ovarian cancer (diagnosed at any age)
  • The year the alteration was found in the patient or five to ten years earlier than the affected family member's age at diagnosis (but not before age 25), taking into consideration individual circumstances and patient preferences.
  • Prior chest radiation therapy
  • At age 25

Consensus-based

*First-degree relative = parent, sibling, or child; second-degree relative = aunt, uncle, grandparent, niece, nephew, or half sibling

6.B. For women with risk factors for breast cancer, annual CBE is recommended. Consensus-based

Magnetic Resonance Imaging (MRI) Screening for Asymptomatic Women without Breast Cancer Risk Factors

7. MRI screening is not recommended for asymptomatic women without breast cancer risk factors. Consensus-based*

*There are currently no studies that determine the accuracy of MRI or its efficacy in reducing important health outcomes for women at average risk of developing breast cancer.

MRI Screening for Asymptomatic Women with Breast Cancer Risk Factors

8. MRI screening is an option for women at very high genetic risk* (whether or not they have genetic testing) as an adjunct to the other screening modalities of mammography, diagnostic ultrasound, and CBE. Consensus-based

*Women at very high genetic risk are defined as those who have a clinically significant BRCA mutation or, in the absence of BRCA genetic test results, women with two first-degree relatives affected with breast or ovarian cancer, at least one of whom has invasive breast cancer diagnosed at <40 years of age or ovarian cancer diagnosed at any age.

Evidence shows that the sensitivity of MRI for tumor detection is higher than that of conventional mammography, but whether this difference in sensitivity has a direct effect on morbidity and/or mortality from breast cancer among patients screened by these methods remains uncertain.

Definitions:

Recommendations are classified as either "evidence-based (A-D, I)" or "consensus-based."

Label and Language of Recommendations

Recommendation Label Recommendation Statement* Evidence-Base
Evidence-Based Recommendations
Evidence-Based, A The Guideline Development Team (GDT) strongly recommends the intervention. The intervention improves important health outcomes, based on good evidence, and the GDT concludes that benefits substantially outweigh harms and costs.
Evidence-Based, B The GDT recommends the intervention. The GDT concludes that the intervention improves important health outcomes, based on 1) good evidence that benefits outweigh harms and costs; or 2) fair evidence that benefits substantially outweigh harms and costs.
Evidence-Based, C The GDT makes no recommendation for or against the intervention.† Evidence is sufficient to determine the benefits, harms, and costs of an intervention, and there is at least fair evidence that the intervention improves important health outcomes. But the GDT concludes that the balance of benefits, harms, and costs is too close to justify a general recommendation.
Evidence-Based, D The GDT recommends against the intervention. The GDT finds at least fair evidence that the intervention is ineffective, or that harms or costs outweigh benefits.
Evidence-Based, I The GDT makes no recommendation for or against the intervention.† The GDT concludes that evidence that the intervention is effective is lacking, of poor quality, or conflicting and the balance of benefits, harms, and costs cannot be determined.
Consensus-Based Recommendations
Consensus-Based The GDT recommends the intervention. The recommendation is based on the consensus of the GDT, typically in the setting of insufficient evidence.
Consensus-Based The GDT has determined that the intervention is an option. The recommendation is based on the consensus of the GDT, typically in the setting of insufficient evidence.
Consensus-Based The GDT recommends against the intervention. The recommendation is based on the consensus of the GDT, typically in the setting of insufficient evidence.
Note that most consensus-based recommendations will have evidence grade "Insufficient." For the rare consensus-based recommendations which have "Good" or "Fair" evidence, the evidence must support a different recommendation, because if the evidence were good or fair, the recommendation would usually be evidence-based. In this kind of consensus-based recommendation the evidence label should point this out, e.g., "Good, supporting a different recommendation."

*All statements specify the population for which the recommendation is intended.

†At the discretion of the GDT, the recommendation may use the language, "option," but must list all the equivalent options.

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

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

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate breast cancer screening

Potential Harms
  • False-positive test leading to unnecessary biopsy, possible treatment and adverse outcomes of treatment, over-diagnosis of breast cancer, identification and treatment of a clinically insignificant (indolent) lesion, unnecessary radiation exposure
  • False-negative test leading to delay in the diagnosis of disease
  • Anxiety
  • Discomfort or pain
  • Refer to the Rationale Statements for individual clinical questions in the original guideline document for details on potential harms of screening procedures

Qualifying Statements

Qualifying Statements
  • This guideline is informational only. It is not intended or designed as a substitute for the reasonable exercise of independent clinical judgment by practitioners, considering each patient's needs on an individual basis.
  • Guideline recommendations apply to populations of patients. Clinical judgment is necessary to design treatment plans for individual patients.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness
Timeliness

Identifying Information and Availability

Bibliographic Source(s)
Kaiser Permanente Care Management Institute. Breast cancer screening clinical practice guideline. Oakland (CA): Kaiser Permanente Care Management Institute; 2010 Aug. 142 p. [112 references]
Adaptation

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

Date Released
2010 Aug
Guideline Developer(s)
Kaiser Permanente Care Management Institute - Managed Care Organization
Source(s) of Funding

Kaiser Permanente Care Management Institute

Guideline Committee

Breast Cancer Screening Guideline Project Management Team

Breast Cancer Screening Guideline Development Team

Composition of Group That Authored the Guideline

Kaiser Permanente (KP) Breast Cancer Screening Guideline Project Management Team: Joanne E Schottinger, MD, Clinical Lead, KP-Southern California; Gladys Tom, MS, Project Manager, Care Management Institute; Yerado Abrahamian, MHS, Analyst, KP-Southern California; Carrie M Davino-Ramaya, MD, Methodologist, Care Management Institute; Tabitha Pousson Staff Assistant Care Management Institute

KP Breast Cancer Screening Guideline Development Team: Colorado: Karin L Kempe, MD, Family Practice & Prevention; Stefanie Kolpak, MD, General Surgeon; Georgia: Peter Burns, MD, Chief, General Surgery; Iris Kolla, MD, Section Chief of Mammography; Fonda Mitchell, MD, MBA, FACOG, Chief of Obstetrics & Gynecology; Hawai'i: Joyce Gilbert, Manager, Breast Care Team; Lucy Wong, MD, Family Practice Physician; Northern California: Janis C Kahn, MD, Chief of Women's Health; Susan E Kutner, MD, Chair, Regional Breast Health Taskforce; Victoria Mancuso, MD, Chief of OB/GYN; Northwest: Catherine A Chester, MD, Physician; Donna R Erbs, MPH, Project Manager; Nicole A Hinkley-Hynes, MD, Physician; Ohio: Henry Adams, MD, Radiology; Mark Binstock, MD, MPH, Physician; William S Schwab, MD, PhD, AGSF, Chief of Geriatrics; Southern California: Marguerite A Koster, MA, MFT, Practice Leader, Guideline Unit; Debra L Reigel, MD, Physician

Financial Disclosures/Conflicts of Interest

There were no conflicts of interest for any member of the Guideline Development Team.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: None available

Print copies: Available from the Kaiser Permanente Care Management Institute, One Kaiser Plaza, 16th Floor, Oakland, CA 94612

Availability of Companion Documents

None available

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on September 22, 2011.

Copyright Statement

For any questions regarding the content of Kaiser Permanente National Clinical Practice Guidelines, please contact Gladys Tom, MS, Manager, CMI at gladys.i.tom@kp.org or (510) 271-2620.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouseâ„¢ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

Read full disclaimer...