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Magnetic Resonance Imaging Screening in Patients at Increased Risk of Breast Cancer - Adult - Ambulatory

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1

Magnetic Resonance Imaging Screening
in Patients at Increased Risk of Breast
Cancer – Adult – Ambulatory
Clinical Practice Guideline


Note: Active Table of Contents – Click to follow link

EXECUTIVE SUMMARY ........................................................................................................... 3
SCOPE ...................................................................................................................................... 4
METHODOLOGY ...................................................................................................................... 4
INTRODUCTION ....................................................................................................................... 5
RECOMMENDATIONS .............................................................................................................. 5
MRI Screening as an Adjunct to Mammography ................................................................ 5
Calculation of Risk ............................................................................................................. 6
Individualized Counseling .................................................................................................. 8
Shared-decision Making .................................................................................................... 8
ALGORITHM FOR BREAST CANCER SCREENING USING MRI IN HIGH RISK PATIENTS . 9
ALGORITHM FOR BREAST CANCER SCREENING USING MRI IN PATIENTS WITH
PERSONAL HISTORY OF TREATED BREAST CANCER ......................................................10
APPENDIX A. EVIDENCE GRADING SCHEME(S) .................................................................12



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2
CPG Contacts for Content:
Name: Roberta Strigel, MD- Radiology
Phone Number: (608) 265-0805
Email Address: rstrigel@uwhealth.org

Name: Heather Neuman, MD- Surgery- General Surgery
Phone Number: (608) 265-5852
Email Address: neuman@surgery.wisc.edu

CPG Contact for Changes:
Name: Lindsey Spencer, MS- Center for Clinical Knowledge Management (CCKM)
Phone Number: (608) 890-6403
Email Address: lspencer2@uwhealth.org

Coordinating Team Members:
Amye Tevaarwerk, MD- Medicine- Hematology/Oncology
Bethany Anderson, MD- Human Oncology- General
Nancy Fuller, MD- Medicine- Internal Medicine/General
Sarina Schrager, MD- Family Medicine- General
Fauzia Khattak, MD- Hematology/Oncology (SwedishAmerican)
Patricia Leh-Murphy- Oncology Genetics
Joanne Becker- Oncology Genetics
Angela Tess- Oncology Genetics
Gina Greenwood- Radiology- Administration
Aimee Arnoldussen, PhD- Center for Clinical Knowledge Management (CCKM)
Jennifer Grice, PharmD, B.C.P.S.- Center for Clinical Knowledge Management (CCKM)

Review Individuals/Bodies:
Wendy DeMartini, MD- Radiology
Lee Wilke, MD- Surgery- General Surgery
Kari Wisinski, MD- Medicine- Hematology/Oncology

Committee Approvals/Dates:
Clinical Knowledge Management (CKM) Council (Last Periodic Review: 08/25/2016)

Release Date: August 2016

Next Review Date: August 2018








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3
Executive Summary
Guideline Overview
This guideline outlines recommendations for MRI screening as adjunct therapy to
mammography for the detection of breast cancer in adult patients at increased risk for breast
cancer.

Key Revisions (2016 Periodic Review)
1. Revised recommendations to emphasize the use of MRI as an adjunct to mammography.
2. Added recommendations for MRI alone in BRCA mutation carriers age 25-29 years.
3. Added additional eligibility criteria, including recently identified genetic mutations and first-
degree relatives of BRCA mutation carriers.
4. Added educational talking points for physician reference during shared-decision making
conversations related to the benefits and limitations of MRI screening.

Key Practice Recommendations
1. Screening is not recommended in patients with severe competing comorbidities and/or short
life expectancy (i.e. < 10 years).1 (UW Health Low quality evidence, weak/conditional
recommendation)
2. Patients may meet any of the following conditions to be considered at increased or high risk
for breast cancer, and eligible for breast MRI screening as an adjunct to mammography:
ξ Confirmed BRCA1 or BRCA2 gene mutations.2 (UW Health Moderate quality evidence,
strong recommendation)
ξ History of chest radiation between 10 and 30 years of age.2 (UW Health Very low quality
evidence, weak/conditional recommendation)
ξ Li-Fraumeni syndrome (TP53) or other hereditary syndrome or mutations (e.g., Peutz-
Jeghers syndrome (STK11), Cowden syndrome (PTEN), or hereditary diffuse gastric
cancer (CDH1), ATM, CHEK2, PALB2).2-4 (UW Health Low quality evidence,
weak/conditional recommendation)
ξ First-degree relative of BRCA mutation carrier, untested.2 (UW Health Low quality evidence,
weak/conditional recommendation)
ξ No personal history of breast cancer and a calculated lifetime cancer risk of > 20%
based on the recommended model(s).2 (UW Health Moderate quality evidence,
weak/conditional recommendation)
ξ Personal history of breast cancer and either 1) a calculated lifetime cancer risk of > 20%
prior to the cancer diagnosis based on the recommended model(s), 2) non-standard
therapy resulting in local cancer recurrence risk after lumpectomy > 20%, and/or 3) < 50
years of age at time of breast cancer diagnosis. (UW Health Low quality evidence,
weak/conditional recommendation)
ξ Personal history of breast cancer and the primary cancer was mammographically occult.
(UW Health Grade Very low quality evidence, weak/conditional recommendation)
ξ Personal history of breast cancer with extremely dense breasts (mammographic breast
density category d). (UW Health Very low quality evidence, weak/conditional recommendation)
3. Providers are encouraged to undergo shared decision making with patients, which includes
a discussion of the benefits and limitations of breast MRI screening along with patient
preferences.5 (UW Health Low quality evidence, strong recommendation)

Companion Documents
1. UW Health Preventive Health Care Guideline
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4
Scope
Disease/Condition(s): Breast Cancer (Increased Risk)

Clinical Specialty: Radiology, Medical Oncology, Surgery, Radiation Oncology, Primary Care

Intended Users: Physicians, Advanced Practice Providers, Genetic Counselors

CPG objective(s): To provide evidence-based guidelines to assist clinicians in determining the
benefits of MRI screening in patients at increased risk for breast cancer.

Target Population:
Individuals (primarily women) at least 18 years of age, and at increased risk for breast cancer.

Interventions and Practices Considered:
ξ Risk assessment
ξ Contrast-enhanced magnetic resonance imaging

Major Outcomes Considered:
ξ Cancer detection
ξ False-positive
Methodology
Methods Used to Collect/Select the Evidence:
Electronic database searches (e.g., PUBMED) were conducted by the guideline author(s) and
workgroup members to collect evidence for review. Expert opinion and clinical experience were
also considered during discussions of the evidence.

Methods Used to Formulate the Recommendations:
The workgroup members agreed to adopt recommendations developed by external
organizations and/or arrived at a consensus through discussion of the literature and expert
experience. All recommendations endorsed or developed by the guideline workgroup were
reviewed and approved by other stakeholders or committees (as appropriate).

Methods Used to Assess the Quality of the Evidence/Strength of the Recommendations:
Recommendations developed by external organizations maintained the evidence grade
assigned within the original source document and were adopted for use at UW Health.

Internally developed recommendations, or those adopted from external sources without an
assigned evidence grade, were evaluated by the guideline workgroup using an algorithm
adapted from the Grading of Recommendations Assessment, Development and Evaluation
(GRADE) methodology (see Figure 1 in Appendix A).

Rating Scheme for the Strength of the Evidence/Recommendations:
See Appendix A for the rating scheme(s) used within this document.

Recognition of Potential Health Care Disparities: No statistically significant differences have
been shown in regard to the use of MRI screening by race or ethnicity, but patients with an
education level of high school or less were less likely to undergo screening than those with a
college degree.6
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Introduction
MRI screening guidelines for women at increased risk of breast cancer have been developed by
the American Cancer Society (ACS) and National Comprehensive Cancer Network (NCCN).2,4,7
However, to date, there have been limited data examining the role of screening MRI in patients
with a personal history of breast cancer. Additionally, no randomized controlled trials have been
performed to evaluate whether screening breast MRI decreases mortality due to breast cancer.

To support UW Health clinicians in their decision-making and discussions with patients, an
algorithm describing the role of MRI screening for breast cancer has been developed which
incorporates the best available data. These guidelines are intended to be a framework upon
which discussions between patients and physicians and other health care professionals
regarding the benefits of MRI screening and areas of related concern are based, rather than an
absolute recommendation.
Recommendations
SPECIAL NOTE
This guideline is intended to support UW Health clinicians in their assessment for the appropriate use of
MRI screening in patients at increased risk for breast cancer. This guideline is separate, but supportive,
of the breast cancer screening recommendations for patients at average risk which are outlined within the
UW Health Preventive Care Guideline. Patients who would benefit from a detailed risk assessment to
determine breast cancer risk and the need for additional interventions should be referred to the UW
Health Prevention, Assessment, Tailored Health Screening (PATHS) clinic.
MRI Screening as an Adjunct to Mammography
Screening is designed to allow for the early detection of cancer, with the goal that early
treatment would result in survival benefit. For patients with serious competing comorbidities
and/or an anticipated short life expectancy, the assumed benefits of screening are not met.
While there is no standard recommended method for assessing life expectancy, screening is not
recommended in patients with severe competing comorbidities and/or short life expectancy (i.e.
< 10 years).1 (UW Health Low quality evidence, weak/conditional recommendation)

Annual MRI screening should only be considered in patients who are willing and able to
undergo MRI and MRI-guided biopsy (no relative or absolute contraindications). Possible
reasons a patient would not be willing or able to undergo MRI and MRI guided biopsy include:
body habitus or weight > 350 pounds, severe claustrophobia, unable to tolerate 45 minutes of
prone positioning, relative contraindications including the requirement of conscious sedation or
general anesthesia to tolerate MRI or previous anaphylactoid reaction to gadolinium (risks of
this would outweigh benefits), and absolute contraindications to MRI/gadolinium contrast,
including devices incompatible with MRI and pregnancy.

Annual MRI screening as an adjunct to mammography for the detection of breast cancer is
recommended in patients at increased or high risk for breast cancer.2,4,5,8,9 (UW Health Moderate
quality evidence, weak/conditional recommendation) The appropriateness of MRI screening for a
given patient should be reassessed annually, considering factors such as remaining life-time
risk of breast cancer, new competing comorbidities, life-expectancy and benefit of MRI as an
adjunct to screening mammograms alone. (UW Health Low quality evidence, weak/conditional
recommendation) Breast MRI screening is preferred over mammography in patients with BRCA
1/2 mutation between the ages of 25 to 29 years.4 (UW Health Low quality evidence, strong
recommendation)

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6
The recommended starting age for MRI screening is typically not before the age of 25 years.4,7
7KH�DFWXDO�VWDUWLQJ�DJH�GHSHQGV�RQ�WKH�UHDVRQ�IRU�VFUHHQLQJ��GHWDLOV�RI�WKH�SDWLHQW¶V�SHUVRQDO�
and family history of breast cancer, as well as consideration of other risk factors.4 (UW Health
Low quality evidence, weak/conditional recommendation) MRI screening after the age of 75years is
not recommended for most women, and for many women of younger age the risks of MRI may
outweigh the benefit. (UW Health Low quality evidence, weak/conditional recommendation)
Calculation of Risk
Patients with a high risk of breast cancer can be identified using family history assessment,
genetic testing, and review of personal clinical history.2 Patients may meet any of the following
conditions to be considered at increased or high risk for breast cancer, and eligible for breast
MRI screening as an adjunct to mammography:
ξ Confirmed BRCA1 or BRCA2 gene mutations.2 (UW Health Moderate quality evidence,
strong recommendation)
ξ History of chest radiation between 10 and 30 years of age.2 (UW Health Very low quality
evidence, weak/conditional recommendation)
ξ Li-Fraumeni syndrome (TP53) or other hereditary syndrome or mutations (e.g., Peutz-
Jeghers syndrome (STK11), Cowden syndrome (PTEN), hereditary diffuse gastric
cancer (CDH1), ATM, CHEK2, or PALB2).2-4 (UW Health Low quality evidence,
weak/conditional recommendation)
ξ First-degree relative of BRCA mutation carrier, untested.2 (UW Health Low quality evidence,
weak/conditional recommendation)
ξ No personal history of breast cancer and a calculated lifetime cancer risk of > 20%
based on the recommended model(s).2 (UW Health Moderate quality evidence,
weak/conditional recommendation)
ξ Personal history of breast cancer and either 1) a calculated lifetime cancer risk of > 20%
prior to the cancer diagnosis based on the recommended model(s), 2) non-standard
therapy resulting in local cancer recurrence risk after lumpectomy > 20%, and/or 3) < 50
years of age at time of breast cancer diagnosis. (UW Health Low quality evidence,
weak/conditional recommendation)
ξ Personal history of breast cancer and the primary cancer was mammographically occult.
(UW Health Grade Very low quality evidence, weak/conditional recommendation)
ξ Personal history of breast cancer with extremely dense breasts (mammographic breast
density category D). (UW Health Very low quality evidence, weak/conditional recommendation)
In most cases, routine MRI screening is not recommended in patients at intermediate risk (e.g.,
calculated lifetime risk of between 15-19%, lobular carcinoma in situ (LCIS), atypical ductal
hyperplasia (ADH), atypical lobular hyperplasia (ALH), or patients with heterogenously or
extremely dense breasts on mammography).2,10 While these factors are known to increase risk,
they interact in complex ways and therefore, screening decisions should be made on an
individual basis.10 A referral to the UW Health Prevention and Tailored Health Screening
(PATHS) clinic can be considered for individualized counseling for patients at an intermediate
risk for breast cancer. (UW Health Very low quality evidence, weak/conditional recommendation)

Risk calculators
Per the ACS and NCCN guidelines, acceptable models to estimate breast cancer risk include
those that are largely dependent on family history, such as the Claus, BRCAPro, and Tyrer-
Cusick (IBIS) models.2,7,11-13 (UW Health Low quality evidence, weak/conditional recommendation)
These risk assessment models may be used in conjunction with one another, as no single
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7
model has been shown to be superior over the others, and each exhibit a unique set of
strengths and limitations.14 The Gail model should not be used to determine eligibility for breast
MRI screening.2,7 (NCCN Category 2A)

Patients with a personal history of treated breast cancer
Many MRI detected cancers/abnormalities identified in the early surveillance period after breast
cancer treatment are likely due to lesions present at diagnosis.15 Therefore, it is recommended
that any patient who will be receiving MRI screening in the future undergo a MRI as part of their
diagnostic work-up for their initial cancer. (UW Health Very low quality evidence, weak/conditional
recommendation) Additionally, to minimize false positive findings, it is recommended MRI
screening to begin AFTER patients have their first post-treatment annual screening
mammogram (MRI approximately 12 - 18 months post-treatment). (UW Health Very low quality
evidence, weak/conditional recommendation)
MRI screening can be considered for patients with a personal history of treated breast cancer
whose lifetime risk prior to the cancer diagnosis exceeds 20%.2,15,16 (UW Health Low quality
evidence, weak/conditional recommendation) For patients with a personal history of breast cancer,
risk should be calculated using a risk calculator by EXCLUDING the personal cancer.
Additionally, patients with a personal history of breast cancer have a 0.25-0.5% per year risk of
developing a second breast cancer.2,17 Assuming a life-expectancy to 90 years, women
diagnosed with breast cancer under the age of 50 will have a life-time risk of breast cancer
which exceeds 20% based on personal history alone. Further, some patients with a personal
history of breast cancer may have a >20% risk of local recurrence as a result of non-standard
therapy (i.e. declined radiation after lumpectomy).
Breast density is a known risk factor for breast cancer.18 However, there is currently no means
to stratify this risk. Patients with extremely dense breast (mammographic density category D)
have greater odds of developing an interval cancer after negative screening mammography
than patients with fatty breasts. Based on these two factors, it is reasonable to consider MRI
screening in patients with a personal history of breast cancer and an extremely dense breast
who do not meet any other criteria for screening MRI.19 (UW Health Very low quality evidence,
weak/conditional recommendation)
Occult primary cancers may occur for a number of reasons including breast density, diffuse
cancer at the time of presentation, and presence of augmentations. Patients are considered to
have occult primary cancers if their primary tumor was not visible on high quality mammography
imaging. Although data regarding risk of a second imaging occult primary or recurrence in this
patient population are limited, retrospective data suggest that ~30% of patients with an occult
primary tumor will have a recurrence or new primary which is also imaging occult.20

Patients with bilateral mastectomy
There is no role for routine MRI screening of women status-post bilateral mastectomy with or
without reconstruction.20 (UW Health Low quality evidence, weak/conditional recommendation)For
patients with a tissue expander and subsequent implant reconstruction, all at-risk tissue is
displaced anteriorly given the subpectoral placement of the implant, and can be easily evaluated
clinically. Imaging has little added utility beyond clinical exam alone.

For patients undergoing autologous reconstruction, there is the potential for recurrence posterior
to the reconstruction on the chest wall. Although limited data exist, this posterior location is
estimated to account for 50% of recurrences; recurrences can also occur in the autologous flap
itself, although this is extremely uncommon. Given the fatty nature of an autologous
reconstruction, mammography is a very sensitive modality for screening in this population.
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8
Therefore, in patients whom clinicians believe have a higher than average recurrence risk that
they are especially concerned about, mammography would be the recommended modality for
screening an autologous breast reconstruction. However, mammographic screening of
autologous breast reconstruction is not routinely recommended.
Individualized Counseling
A referral to the UW Health Prevention and Tailored Health Screening (PATHS) clinic can be
considered for individualized counseling for patients potentially at high risk for breast cancer,
including those with a family history of breast cancer, prior chest radiation, or a hereditary
syndrome. (UW Health Very low quality evidence, weak/conditional recommendation) This clinic exists
to screen, counsel, treat, and follow patients at high risk for the development of breast
malignancies. Referral to the PATHS clinic can be made through the UW Health Breast Center
by telephone (608-266-6400) or through Health LLQN��OLVWLQJ�³KLJK-risk for breast cancer,
HYDOXDWH�ULVN´�DV�WKH�UHDVRQ�IRU�UHIHUUDO��
Shared-decision Making
Providers are encouraged to undergo shared decision making with patients, which includes a
discussion of the benefits and limitations of breast MRI screening along with patient
preferences.5 (UW Health Low quality evidence, strong recommendation) Possible reasons a patient
may not be willing or able to undergo MRI and MRI guided biopsy include: body habitus or
weight > 350 pounds, severe claustrophobia, unable to tolerate 45 minutes of prone positioning,
relative contraindications including the requirement of conscious sedation or general
anesthesia to tolerate MRI or previous anaphylactoid reaction to gadolinium (risks of this would
outweigh benefits), and absolute contraindications to MRI/gadolinium contrast, including devices
incompatible with MRI and pregnancy.

As with any additional imaging, the opportunity to have a false positive result is greater with
added tests. However, the cancer detection rates are also higher, as demonstrated in Table 1.

Table 1. Added Value of Breast MRI in Detecting Cancer in Patients at High Risk for Breast Cancer
Mammography MRI Mammography + MRI

Author/Trial Year Sensitivity Sensitivity Sensitivity
Kriege21 2004 40% 71% 89%
Kuhl22 2005 33% 91% 93%
Leach (MARIBS)23 2005 40% 77% 94%
Sardanelli
(HIBCRIT)24 2007 60% 87% 100%
Kuhl (EVA) 2010 33% 93% 100%
Rijnsburger (MRISC) 2010 41% 68% 84%
Passaperuma
(Canadian)25 2012 20% 91% 94%
Totals 36% 80% 91%
*Includes prospective studies of screening MRI involving multiple screening rounds, in which at least 10 cancers were identified.
Table adapted from Sickles (2010).26
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9
Algorithm for Breast Cancer Screening using MRI in High Risk Patients
Patient
presentation
Does the patient have at-risk
breast tissue
(did not have bilateral
mastectomies)?
MRI screening not
recommended.
No
Is the patient willing/able to
undergo MRI and biopsy?
Yes
Without considering personal
history of breast cancer, at
least 10 years of life
expectancy?
Yes
BRCA mutation carrier?
Yes
Chest radiation between age
10 and 30 years, or
Li-Fraumeni or other
hereditary syndrome?
No
Personal history of breast
cancer?
No
Using accepted model(s), is
calculated lifetime risk
> 20%?
No
MRI screening not
recommended.
No
Consider MRI screening
after discussion of pros
and cons.
Yes
Consider MRI screening
after discussion of pros
and cons.
Yes
Refer to Screening in
Patients with Personal
History Algorithm.
Yes
Consider MRI screening
after discussion of pros
and cons.
Yes
MRI screening not
recommend.
No
MRI screening not
recommended.
No
Note: Accepted risk models include BRCAPro, Tyrer-Cusick, and Claus.
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10
Algorithm for Breast Cancer Screening using MRI in Patients with Personal
History of Treated Breast Cancer

Patient presentation with personal
history of breast cancer
Does the patient meet any of the following criteria:
ξ Using accepted model(s), is calculated lifetime
risk > 20%?
ξ Did patient receive non-standard therapy
resulting in a local recurrence risk after
lumpectomy > 20%?
ξ Was the patient < 50 years of age at time of
breast cancer diagnosis?
Was the primary cancer
mammographically occult?
Does the patient have
extremely dense breasts
(mammographic density
category D)?
No
No
Consider MRI screening
after discussion of pros
and cons.
Yes
Consider MRI screening
after discussion of pros
and cons.
Yes
MRI screening not
recommend.
No
Consider MRI screening
after discussion of pros
and cons.
Yes

Note: Accepted risk models include BRCAPro, Tyrer-Cuick, and Claus.
Risk should be calculated EXCLUDING the personal cancer.
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11
UW Health Implementation
Potential Benefits:
ξ Early detection of breast cancer and improved chance of survivorship

Potential Harms:
ξ False-positive

Qualifying Statements: This guideline is intended to support the assessment and screening
recommendations for patients at increased risk for breast cancer. This guideline is separate
but supportive of the breast cancer screening recommendations for patients at average risk that
are outlined in the UW Health Preventive Health Care Guideline.

Patients who would benefit from a detailed risk-assessment to determine breast cancer risk and
the need for additional interventions should be referred to the UW Health Prevention,
Assessment, Tailored Health Screening (PATHS) clinic. Referral to the PATHS clinic can be
made through the UW Breast Center by telephone (608-266-6400) or through Health Link,
OLVWLQJ�³KLJK-ULVN�IRU�EUHDVW�FDQFHU��HYDOXDWH�ULVN´�DV�WKH�UHDVRQ�IRU�UHIHUUDO�´�

Pertinent UW Health Policies & Procedures
None identified.

Patient Resources
1. HFFY #5939: Breast MRI
2. HFFY #6889: Breast MRI For Patients from a Correctional Facility
3. Healthwise: MRI of the Breast: About This Test
4. Health Information: Breast Cancer Screening
5. Health Information: Breast Cancer Screening and Dense Breasts: What Are My Options?
6. Health Information: Breast Cancer: What Should I Do If I¶P�DW�+LJK�5LVN"

Guideline Metrics:
1. Number of high risk patients with breast cancer detected by MRI
2. Overall health outcomes of at-risk patients diagnosed with breast cancer with and without
application of MRI

Implementation Plan/Clinical Tools
1. Guideline will be posted on uConnect in a dedicated location for Clinical Practice Guidelines.
2. Release of the guideline will be advertised in the Physician/APP Briefing newsletter.
3. Content and hyperlinks within clinical tools, documents, or Health Link related to the
guideline recommendations (such as the following) will be reviewed for consistency and
modified as appropriate.

EAP Record
MRI Breast Bilateral with and/or without Contrast [R77059]

Disclaimer
CPGs are described to assist clinicians by providing a framework for the evaluation and
treatment of patients. This Clinical Practice Guideline outlines the preferred approach for most
SDWLHQWV���,W�LV�QRW�LQWHQGHG�WR�UHSODFH�D�FOLQLFLDQ¶V�MXGJPHQW�RU�WR�HVWDEOLVK�D�SURWRFRO�IRU�DOO�
patients. It is understood that some patients will not fit the clinical condition contemplated by a
guideline and that a guideline will rarely establish the only appropriate approach to a problem.
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Appendix A. Evidence Grading Scheme(s)

Figure 1. GRADE Methodology adapted by UW Health

GRADE Ranking of Evidence
High We are confident that the effect in the study reflects the actual effect.
Moderate We are quite confident that the effect in the study is close to the true effect, but it
is also possible it is substantially different.
Low The true effect may differ significantly from the estimate.
Very Low The true effect is likely to be substantially different from the estimated effect.

GRADE Ratings for Recommendations For or Against Practice
Strong The net benefit of the treatment is clear, patient values and circumstances
are unlikely to affect the decision.
Weak/conditional
Recommendation may be conditional upon patient values and
preferences, the resources available, or the setting in which the
intervention will be implemented.

Figure 2. NCCN Grading Scheme
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