Guideline Title
Guidelines of care for the management of primary cutaneous melanoma.
Bibliographic Source(s)
Bichakjian CK, Halpern AC, Johnson TM, Foote Hood A, Grichnik JM, Swetter SM, Tsao H, Barbosa VH, Chuang TY, Duvic M, Ho VC, Sober AJ, Beutner KR, Bhushan R, Smith Begolka W, American Academy of Dermatology. Guidelines of care for the management of primary cutaneous melanoma. J Am Acad Dermatol 2011 Nov;65(5):1032-47. [143 references] PubMed  |
Guideline Status
This is the current release of the guideline.
This guideline updates a previous version: Guidelines of care for primary cutaneous melanoma. J Am Acad Dermatol 2001 Oct;45(4):579-86. [44 references]
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Disease/Condition(s)
Primary cutaneous melanoma (including those in the nail unit)
Note: The guideline does not address primary melanoma of the mucous membranes.
Guideline Category
Diagnosis
Management
Treatment
Clinical Specialty
Dermatology
Family Practice
Oncology
Pathology
Surgery
Intended Users
Physicians
Guideline Objective(s)
To address the treatment of patients with primary cutaneous melanoma (including those in the nail unit), who may also have clinical or histologic evidence of regional disease, from the perspective of the U.S. dermatologist
Target Population
Patients with primary cutaneous melanoma (including those in the nail unit), who may also have clinical or histologic evidence of regional disease
Interventions and Practices Considered
Diagnosis/Evaluation
- Biopsy technique
- Excision of lesion with narrow margins
- Incisional biopsy in selected cases
- Repeat biopsy if initial biopsy specimen is inadequate for accurate histologic diagnosis or staging
- Clinical and histologic information to be included in pathology report
- Baseline and surveillance laboratory tests and imaging studies (generally not recommended)
Treatment/Management
- Surgical excision (surgical margins based on tumor thickness)
- Nonsurgical treatments
- Imiquimod
- Radiation therapy
- Cryosurgery
- Observation
- Sentinel lymph node biopsy
- Routine follow-up (history and physical examination) at least annually
Major Outcomes Considered
- Morbidity and mortality
- Local recurrence of melanoma
- Detection of occult metastatic disease
- Prognostic value of histologic characteristics
- Survival
- Quality of life
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Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence
A work group of recognized melanoma experts was convened to determine the audience and scope of the guideline, and identify important clinical questions in the management of primary cutaneous melanoma (see Table I in the original guideline document).
An evidence-based model was used and evidence was obtained using a search of the PubMed database spanning the years 2000 through 2010 for clinical questions addressed in the previous version of this guideline published in 2001, and 1960 to 2010 for all newly identified clinical questions. Only English-language publications were reviewed. Published guidelines on melanoma were also evaluated.
Number of Source Documents
Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus (Committee)
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence
Evidence was graded using a 3-point scale based on the quality of methodology as follows:
- Good-quality patient-oriented evidence (i.e., evidence measuring outcomes that matter to patients: morbidity, mortality, symptom improvement, cost reduction, and quality of life)
- Limited-quality patient-oriented evidence
- Other evidence including consensus guidelines, opinion, case studies, or disease-oriented evidence (i.e., evidence measuring intermediate, physiologic, or surrogate end points that may or may not reflect improvements in patient outcomes)
Methods Used to Analyze the Evidence
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence
The available evidence was evaluated using a unified system called the Strength of Recommendation Taxonomy developed by editors of the United States (U.S.) family medicine and primary care journals (i.e., American Family Physician, Family Medicine, Journal of Family Practice, and BMJ USA). This strategy was supported by a decision of the Clinical Guidelines Task Force in 2005 with some minor modifications for a consistent approach to rating the strength of the evidence of scientific studies.
Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations
Clinical recommendations were developed on the best available evidence tabled in the guideline. In those situations where documented evidence-based data are not available, expert opinion was used to generate clinical recommendations.
Rating Scheme for the Strength of the Recommendations
- Recommendation based on consistent and good quality patient-oriented evidence
- Recommendation based on inconsistent or limited quality patient-oriented evidence
- Recommendation based on consensus, opinion, or case studies
Cost Analysis
Published cost analyses were reviewed.
Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation
This guideline has been developed in accordance with the American Academy of Dermatology (AAD)/AAD Association "Administrative Regulations for Evidence-based Clinical Practice Guidelines" (version approved March 2009), which include the opportunity for review and comment by the entire AAD membership and final review and approval by the AAD Board of Directors.
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Major Recommendations
Level of evidence grades (I-III) and strength of recommendations (A-C) are defined at the end of the "Major Recommendations" field.
Table: Strength of Recommendations for Management of Primary Cutaneous Melanoma
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Strength of Recommendation |
Level of Evidence |
References |
| Biopsy |
B |
II |
Stell et al., 2007; Karimipour et al., 2005; Austin et al., 1996; Ng et al., 2010; Pariser, Divers, & Nassar, 1999; Ng et al., 2003; Armour, Mann, & Lee, 2005; Bong, Herd, & Hunter, 2002; Lederman & Sober, 1985; Lees & Briggs, 1991; Martin et al., 2005 |
| Pathology Report: |
Clinical Information |
A |
I-II |
Corona et al, 1994; Mansson-Brahme et al., 1994; Schuchter et al., 1996; Halpern, & Schuchter, 1997; Gimotty et al., 2004; Massi et al., 1999; Francken et al., 2004;. Nagore et al., 2005; Leiter et al., 2004; Cochran et al., 2000; Balch et al., 2000; Levi et al. 1998; Sahin et al., 1997; Straume & Akslen, 1996; Eldh, Boeryd, & Peterson, 1978 |
Tumor (Breslow) thickness |
A |
I-II |
Balch et al., 2009; Corona et al, 1994; Mansson-Brahme et al., 1994; Schuchter et al., 1996; Halpern & Schuchter, 1997; Massi et al., 1999; Nagore et al., 2005; Leiter et al., 2004; Cochran et al., 2000; Balch et al., 2000; Levi et al., 1998; Sahin et al., 1997; Eldh, Boeryd, & Peterson, 1978; Barnhill et al., 2005; Barnhill et al., 1996; Marghoob et al., 2000; Massi et al., 2000; Eigentler et al., 2004; Thorn et al., 1996; Clemente et al., 1996; Taran & Heenan, 2001 |
Ulceration |
A |
I-II |
Balch et al., 2009; Corona et al, 1994; Nagore et al., 2005; Cochran et al., 2000; Balch et al., 2000; Eldh, Boeryd, & Peterson, 1978; Barnhill et al., 2005; Barnhill et al., 1996; Massi et al., 2000; Eigentler et al., 2004 |
Mitotic rate |
A |
I-II |
Balch et al., 2009; Halpern & Schuchter, 1997; Gimotty et al., 2004; Francken et al., 2004; Nagore et al., 2005; Eldh, Boeryd, & Peterson, 1978; Clark et al., 1989; Barnhill et al., 1996; Azzola et al., 2003; Massi et al., 2000 |
Level of invasion (Clark) |
B |
II |
Balch et al., 2009; Mansson-Brahme et al., 1994; Halpern & Schuchter, 1997; Gimotty et al., 2004; Massi et al., 1999; Nagore et al., 2005; Straume & Akslen, 1996; Eldh, Boeryd, & Peterson, 1978; Clark et al., 1989; Barnhill et al., 1996; Marghoob et al., 2000; Thorn et al., 1996 |
Microsatellitosis |
B |
I-II |
Balch et al., 2009; Nagore et al., 2005; Barnhill et al., 1996; Kimsey et al., 2009; Shaikh et al., 2005; Rao et al., 2002 |
Angiolymphatic invasion |
B |
II |
Nagore et al., 2005; Straume & Akslen, 1996; Barnhill et al., 1996; Massi et al., 2000 |
Histologic subtype |
B |
II |
Halpern & Schuchter, 1997; Massi et al., 1999; Leiter et al., 2004; Levi et al., 1998; Barnhill et al., 1996; Massi et al., 2000 |
Regression |
B |
II |
Mansson-Brahme et al., 1994; Halpern & Schuchter, 1997; Clark et al., 1989; Barnhill et al., 1996; Taran & Heenan, 2001 |
Tumor-infiltrating lymphocytes |
B |
II |
Mansson-Brahme et al., 1994; Halpern & Schuchter, 1997; Massi et al., 1999; Clark et al., 1989; Thorn et al., 1996; Clemente et al., 1996 |
| Staging workup |
B |
II-III |
Wang et al., 2004; Fogarty & Tartaguia, 2006; Miranda et al., 2004; Hafner et al., 2004; Yancovitz et al., 2007; Hofmann et al., 2002; Ho Shon et al., 2008; Krug et al., 2008; Aloia et al., 2006; Gold et al., 2007; Tsao et al., 2004 |
| Follow-Up: |
Interval |
B |
II |
Hofmann et al., 2002; Francken et al., 2008; Garbe et al., 2003; Dalal et al., 2007 |
Duration |
B |
II |
DiFronzo et al., 1999; Ferrone et al., 2005; Francken et al., 2008; Goggins & Tsao, 2003; McCaul et al., 2008 |
Patient skin/self-evaluation |
B |
II |
Pollitt et al., 2009; Moore et al., 2008 |
Imaging and laboratory tests |
B |
II |
Hofmann et al., 2002; Bafounta et al., 2004; Machet et al., 2005; Garbe et al., 2003; Weiss et al., 1995; Morton, Craig, & Thompson, 2009 |
| Surgical management |
In situ |
C |
III |
No clinical trials |
≤1.0-mm thickness |
A |
I |
Veronesi, & Cascinelli, 1991; Veronesi et al., 1988; Cascinelli, 1998; Ringborg et al., 1996; Cohn-Cedermark et al., 2000; Khayat et al., 2003 |
1.01- to 2-mm thickness |
A |
I |
Balch et al., 2000; Lens, Nathan, & Bataille, 2007; Veronesi, & Cascinelli, 1991; Veronesi et al., 1988; Cascinelli, 1998; Ringborg et al., 1996; Cohn-Cedermark et al., 2000; Khayat et al., 2003; Karakousis et al., 1996; Balch et al., 1993 |
>2-mm thickness |
B |
I-III |
Balch et al., 2000; Karakousis et al., 1996; Balch et al., 1993; Heaton et al., 1998 |
| Non-surgical treatments: |
Imiquimod |
C |
III |
Buettiker et al., 2008; Cotter, McKenna, & Bowen. 2008; Naylor et al., 2003; Powell et al., 2009; Spenny et al., 2007 |
Radiotherapy |
C |
III |
Schmid-Wendtner et al., 2000; Tsang et al., 1994; Farshad et al., 2002; Harwood, 1983 |
Cryosurgery |
C |
III |
Kuflik & Gage, 1994; Collins et al., 1991; Bohler-Sommeregger et al., 1992; Dawber & Wilkinson, 1979; Zacarian et al., 1982 |
| Sentinel lymph node biopsy |
B |
I-III |
Balch et al., 2009; Mattsson et al., 2008; Rossi et al., 2006; Testori et al., 2009; Gershenwald et al., 2000; Ferrone et al., 2002; Morton et al., 2006; Kingham et al., 2010; Nowecki, Rutkowski, & Michej, 2008; Wong et al., 2006; Bleicher et al., 2003; Ranieri et al., 2006; Warycha et al., 2009; Wong et al., 2005; Wright et al., 2008; Gutzmer et al., 2008 |
Recommendations for Biopsy
- Preferred biopsy technique is narrow excisional biopsy that encompasses entire breadth of lesion with clinically negative margins to depth sufficient to ensure that lesion is not transected, which may be accomplished by elliptical or punch excision with sutures, or shave removal to depth below anticipated plane of lesion.
- Partial sampling (incisional biopsy) is acceptable in select clinical circumstances such as facial or acral location, low clinical suspicion or uncertainty of diagnosis, or very large lesion.
- Repeat biopsy is recommended if initial biopsy specimen is inadequate for diagnosis or microstaging of primary lesion.
Table: Recommended Clinical Information to Be Provided to Pathologist
| Essential |
Strongly Recommended |
Optional |
| Age of Patient |
Biopsy technique (excisional or incisional) |
Clinical description and level of clinical suspicion |
| Gender |
Size of lesion |
Dermatoscopic features |
| Anatomic location |
|
Photograph |
| |
|
Macroscopic satellitosis |
Table: Recommended Histologic Features of Primary Melanoma to Be Included in Pathology Report
| Essential |
Optional |
| Tumor (Breslow) thickness, mm |
Angiolymphatic invasion |
| Ulceration |
Histologic subtype |
| Dermal mitotic rate, mitoses/mm2 |
Neurotropism |
| Peripheral and deep margin status (positive or negative) |
Regression |
| Anatomic level of invasion (Clark level)* |
T-stage classification |
| Microsatellitosis |
Tumor infiltrating lymphocytes |
| |
Vertical growth phase |
*Essential for staging only in tumors ≤1mm in thickness when mitotic rate cannot be assessed; optional for tumors >1 mm in thickness.
Recommendations for Staging Workup and Follow-up
- Baseline laboratory tests and imaging studies are generally not recommended in asymptomatic patients with newly diagnosed primary melanoma of any thickness.
- No clear data regarding follow-up interval exist, but at least annual history and physical examination with attention to skin and lymph nodes is recommended.
- Regular clinical follow-up and interval patient self-examination of skin and regional lymph nodes are most important means of detecting recurrent disease or new primary melanoma; findings from history and physical examination should direct need for further studies to detect local, regional, and distant metastasis.
- Surveillance laboratory tests and imaging studies in asymptomatic patients with melanoma have low yield for detection of metastatic disease and are associated with relatively high false-positive rates.
Table: Surgical Margin Recommendations for Primary Cutaneous Melanoma
| Tumor Thickness |
Clinically Measured Surgical Margin* |
| In situ |
0.5–1.0 cm |
| ≤1.0 mm |
1 cm |
| 1.01–2.0 mm |
1–2 cm |
| >2.0 mm |
2 cm |
*Wider margins may be necessary for lentigo maligna subtype.
Recommendations for Surgical Management
- Treatment of choice for primary cutaneous melanoma of any thickness is surgical excision with histologically negative margins.
- Surgical margins for invasive melanoma should be at least 1 cm and no more than 2 cm clinically measured around primary tumor; clinically measured surgical margins do not need to correlate with histologically negative margins.
- For melanoma in situ, wide excision with 0.5- to 1.0-cm margins is recommended; lentigo maligna histologic subtype may require >0.5-cm margins to achieve histologically negative margins, because of characteristically broad subclinical extension.
Recommendations for Nonsurgical Treatments
- Nonsurgical therapy for primary cutaneous melanoma should only be considered under select clinical circumstances, when surgical excision is not feasible.
- Alternatives to surgery include topical imiquimod, radiation therapy, cryosurgery, and observation.
- Efficacy of nonsurgical therapies for lentigo maligna has not been fully established.
Recommendations for Sentinel Lymph Node Biopsy (SLNB)
- Status of sentinel lymph node (SLN) is most important prognostic indicator for disease-specific survival in patients with primary cutaneous melanoma; impact of SLNB on overall survival remains unclear.
- SLNB is not recommended for patients with melanoma in situ or T1a melanoma.
- SLNB should be considered in patients with melanoma >1 mm in tumor thickness.
- In patients with T1b melanoma, 0.76–1.00 mm in tumor thickness, SLNB should be discussed; in T1b melanoma, with tumor thickness ≤0.75 mm, SLNB should generally not be considered, unless other adverse parameters in addition to ulceration or increased mitotic rate are present, such as angiolymphatic invasion, positive deep margin, or young age.
Definitions:
Level of Evidence
- Good-quality patient-oriented evidence (i.e., evidence measuring outcomes that matter to patients: morbidity, mortality, symptom improvement, cost reduction, and quality of life)
- Limited-quality patient-oriented evidence
- Other evidence including consensus guidelines, opinion, case studies, or disease-oriented evidence (i.e., evidence measuring intermediate, physiologic, or surrogate end points that may or may not reflect improvements in patient outcomes)
Grade of Recommendation
- Recommendation based on consistent and good quality patient-oriented evidence
- Recommendation based on inconsistent or limited quality patient-oriented evidence
- Recommendation based on consensus, opinion, or case studies
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Evidence Supporting the Recommendations
References Supporting the Recommendations
Type of Evidence Supporting the Recommendations
The type of supporting evidence is identified and graded for selected recommendations (see the "Major Recommendations" field).
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Benefits/Harms of Implementing the Guideline Recommendations
Potential Benefits
- Improved early detection and management of primary cutaneous melanoma
- Reduced morbidity and mortality through the detection of asymptomatic metastases and additional primary melanomas
Potential Harms
- The limitations of all nonsurgical treatment modalities must clearly be discussed with patients when considering any alternative therapies, including the risk of missing and undertreating invasive melanoma by not microstaging the primary lesion; higher local recurrence rates because of a lack of margin control; and the absence of long-term, randomized, controlled comparative studies.
- As an adjunctive modality after surgical excision, the efficacy of topical imiquimod has not been established. High cost of treatment, an appropriate low threshold for subsequent biopsy to exclude residual or recurrent disease, and the risk of a severe inflammatory reaction should be taken into account when considering imiquimod.
- The impact of false-positive findings, whether by positron-emission tomography (PET), computed tomography, chest x-ray, or lactate dehydrogenase, that lead to unnecessary invasive procedures and substantial patient anxiety, should not be underestimated.
- Postoperative complications of sentinel lymph node biopsy
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Qualifying Statements
Adherence to these guidelines will not ensure successful treatment in every situation. Furthermore, these guidelines should not be interpreted as setting a standard of care, or be deemed inclusive of all proper methods of care nor exclusive of other methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific therapy must be made by the physician and the patient in light of all the circumstances presented by the individual patient, and the known variability and biological behavior of the disease. This guideline reflects the best available data at the time the guideline was prepared.
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Implementation of the Guideline
Description of Implementation Strategy
An implementation strategy was not provided.
Implementation Tools
Patient ResourcesFor information about availability, see the Availability of Companion Documents and Patient Resources fields below.
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Institute of Medicine (IOM) National Healthcare Quality Report Categories
IOM Care Need
Getting Better
Living with Illness
IOM Domain
Effectiveness
Patient-centeredness
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Identifying Information and Availability
Bibliographic Source(s)
| Bichakjian CK, Halpern AC, Johnson TM, Foote Hood A, Grichnik JM, Swetter SM, Tsao H, Barbosa VH, Chuang TY, Duvic M, Ho VC, Sober AJ, Beutner KR, Bhushan R, Smith Begolka W, American Academy of Dermatology. Guidelines of care for the management of primary cutaneous melanoma. J Am Acad Dermatol 2011 Nov;65(5):1032-47. [143 references] PubMed |
Adaptation
Not applicable: The guideline was not adapted from another source.
Date Released
2001 Mar (revised 2011 Nov)
Guideline Developer(s)
American Academy of Dermatology - Medical Specialty Society
Source(s) of Funding
American Academy of Dermatology operational funds and member volunteer time supported the development of this guideline.
Guideline Committee
Primary Cutaneous Melanoma Work Group
Composition of Group That Authored the Guideline
Work Group Members: Christopher K. Bichakjian, MD, Department of Dermatology, University of Michigan Health System and Comprehensive Cancer Center; Allan C. Halpern, MD (Co-chair), Department of Dermatology, Memorial Sloan-Kettering Cancer Center, New York; Timothy M. Johnson, MD (Co-Chair), Department of Dermatology, University of Michigan Health System and Comprehensive Cancer Center; Antoinette Foote Hood, MD, Department of Dermatology, Eastern Virginia Medical School; James M. Grichnik, MD, PhD, Department of Dermatology, University of Miami Health System, University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center, Melanoma Program; Susan M. Swetter, MD, Department of Dermatology, Stanford University Medical Center and Department of Veterans Affairs Palo Alto Health Care System; Hensin Tsao, MD, PhD, Department of Dermatology, Massachusetts General Hospital and Harvard Medical School; Victoria Holloway Barbosa, MD, Department of Dermatology, Rush University Medical Center, Chicago; Tsu-Yi Chuang, MD, MPH, University of Southern California, Los Angeles, and Desert Oasis Healthcare, Palm Springs; Madeleine Duvic, MD, Department of Dermatology, University of Texas MD Anderson Cancer Center; Vincent C. Ho, MD, Division of Dermatology, University of British Columbia; Arthur J. Sober, MD, Department of Dermatology, Massachusetts General Hospital and Harvard Medical School; Karl R. Beutner, MD, PhD, Department of Dermatology, University of California, San Francisco, and Solano Dermatology, Fairfield; Reva Bhushan, PhD, American Academy of Dermatology, Schaumburg; and Wendy Smith Begolka, MS, American Academy of Dermatology, Schaumburg
Financial Disclosures/Conflicts of Interest
Work group members completed a disclosure of commercial support that was updated throughout guideline development.
Allan C. Halpern, MD, served on the Advisory Board for DermTech and Roche receiving other financial benefits, was a consultant with Canfield Scientific receiving other financial benefits, and was an investigator with Lucid, Inc receiving no compensation.
James M. Grichnik, MD, PhD, served as founder of Digital Derm Inc receiving stock and was consultant for Genentech, MELA Science, Inc and Spectral Image, In. receiving honoraria.
Hensin Tsao, MD, PhD, served as consultant for Genentech, Quest Diagnostics, SciBASE, and Metamark receiving honoraria.
Victoria Holloway Barbosa, MD, served as founder of Dermal Insights Inc receiving stocks, and as consultant for L'Oreal USA receiving other benefits, and served another role with Pierre Fabre receiving other benefits.
Madeleine Duvic, MD, served as investigator and on the advisory board for Allos and BioCryst receiving grants and honoraria, and as investigator and consultant for Celgeene, Kyowa Hakko Kirin Pharma, and Merck receiving grants and honoraria, serving as consulting for Dermatex, Hoffman-La Roche, Millennium Pharmaceuticals, Vertex, and Upside Endeavers, LLC, receiving honoraria; serving as consultant, investigator, and speaker for Eisai receiving grants and honoraria, serving as investigator for Eli Lilly, Genmab, Hannah Biosciences, NAAF, Hobartis, OrthoBiotech MSK, Pfizer, Sloan Kettering, Spectrum, Therakos, Topotarget, and Yapon Therapeutics receiving grants and also as investigator for NIH receiving salary; served as a speaker for P4 Healthcare and Peer Direct receiving honoraria; and, lastly, served on advisory board for Quintiles Pharma and Seattle Genetics receiving honoraria.
Vincent C. Ho, MD, served on the advisory board and as an investigator and speaker for Abbott, Janssen Ortho and Schering, receiving grants and honoraria, served on advisory board and as investigator for Amgen receiving grants and honoraria, served on the advisory board for Astellas and Basilea receiving honoraria, and served as investigator for Centocor, Novartis and Pfizer receiving grants.
Arthur J. Sober, MD, served as a consultant for MelaScience receiving other benefits.
Karl R. Beutner, MD, PhD, Chair Clinical Research Committee, served as a consultant of Anacor receiving stock, stock options, and honoraria.
Christopher K. Bichakjian, MD, Timothy M. Johnson, MD, Antoinette Foote Hood, MD, Susan M. Swetter, MD, Tsu-Yi Chuang, MD, MPH, Reva Bhushan, MA, PhD, and Wendy Smith Begolka, MS, had no relevant conflicts of interest to disclose.
Guideline Status
This is the current release of the guideline.
This guideline updates a previous version: Guidelines of care for primary cutaneous melanoma. J Am Acad Dermatol 2001 Oct;45(4):579-86. [44 references]
Availability of Companion Documents
Patient Resources
The following is available:
Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.
NGC Status
This summary was completed by ECRI on April 30, 2001. The information was verified by the guideline developer on May 14, 2001. This summary was updated by ECRI Institute on July 16, 2012.
Copyright Statement
This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.
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