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## Complete Summary

#### GUIDELINE TITLE

Cutaneous melanoma. A national clinical guideline.

#### BIBLIOGRAPHIC SOURCE(S)

Scottish Intercollegiate Guidelines Network (SIGN). Cutaneous melanoma.
A national clinical guideline. Edinburgh (Scotland): Scottish
Intercollegiate Guidelines Network (SIGN); 2003 Jul. 50 p. (SIGN
publication; no. 72). \[277 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

Any amendments to the guideline in the interim period will be noted on
[Scottish Intercollegiate Guidelines Network (SIGN) Web
site](http://www.sign.ac.uk/new.html).

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Cutaneous melanoma

**Note**: The guideline does not address melanomas of non-cutaneous
origin such as melanomas arising from mucosae, ocular melanomas, and
other rare non-cutaneous sites.

#### GUIDELINE CATEGORY

Diagnosis\
Management\
Prevention\
Treatment

#### CLINICAL SPECIALTY

Dermatology\
Family Practice\
Internal Medicine\
Obstetrics and Gynecology\
Oncology\
Pathology\
Radiation Oncology\
Surgery

#### INTENDED USERS

Advanced Practice Nurses\
Allied Health Personnel\
Nurses\
Physician Assistants\
Physicians\
Public Health Departments

#### GUIDELINE OBJECTIVE(S)

To provide advice at all stages of the patient\'s pathway of care, from
primary prevention to early recognition, treatment, and follow up

#### TARGET POPULATION

Individuals at risk for and/or diagnosed with cutaneous melanoma

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Prevention**

1.  Public education on the use of sun protective measures (e.g.,
    sunscreen and clothing) and identification of risk factors

    -   Non-alarmist brochures and leaflets

    -   Interactive computer programmes (considered but not recommended)

**Screening** (considered but not recommended)

**Diagnosis**

1.  Assessment with or without magnification according to the 7 point
    checklist or ABCDE system

2.  Hand held dermatoscopy

3.  Biopsy

4.  Pathological diagnosis and microscopic staging

    -   Essential features:

        -   Breslow thickness

        -   Clark level (if Breslow thickness \<1mm)

        -   Ulceration

        -   Growth phase characteristics

        -   Regression

        -   Lymphovascular space invasion

        -   Microscopic satellites

        -   Microscopic clearance (mm)

    -   Desirable features:

        -   Histogenetic type

        -   Cell type

        -   Host inflammatory response

        -   Mitotic rate

**Management**

*Surgical management and staging*

1.  Surgical excision with recommended tumour clearance

2.  Radical lymph node dissection

3.  Elective lymph node dissection

4.  Sentinel lymph node biopsy (SLNB)

5.  Surgical management considered but not routinely recommended:

    -   Examination of the regional lymph node basin and fine needle
        aspiration cytology (FNAC), if palpable

    -   Isolated limb perfusion (ILP) with melphalan and/or Tissue
        Necrosis Factor

    -   Carbon dioxide laser ablation

    -   Other methods such as cryotherapy, intralesional bacilli
        Calmette-Guerin (BCG) and radiotherapy

*Further investigations and non-surgical staging*

1.  Assessment of metastatic spread (discussed but not specifically
    recommended) including:

    -   Surgery (SLNB)

    -   Imaging (conventional radiotherapy, ultrasound scanning (US),
        computerized tomography (CT), magnetic resonance imaging (MRI),
        and positron emission tomography (PET)

    -   Blood tests (routine haematology, tumour markers, liver function
        tests and lactic dehydrogenase (LDH)

**Treatment**

*Adjuvant treatment (stage II and III) & follow-up (stage I, II and
III)*

1.  Treatments (stage II and III) considered but not routinely
    recommended include:

    -   Radiotherapy

    -   Adjuvant interferon

    -   Vaccines

2.  Follow up considered but not routinely recommended:

    -   Frequency and duration of follow up

    -   Psychological and emotional support

    -   Laboratory tests

    -   Imaging

3.  Patient education regarding sun protection, features of melanoma and
    skin self examination

*Management/Treatment (stage IV)*

1.  Metastasectomy (considered but not recommended)

2.  Surgical resection of central nervous system disease, as appropriate

3.  Chemotherapy, chemoimmunotherapy and immunotherapy

    -   Single agent therapy (Dacarbazine)

    -   Combination therapy is not recommended

4.  Radiotherapy

    -   Single dose

    -   Whole brain radiotherapy combined with corticosteroids for
        central nervous system disease

5.  Specialist palliative care team

6.  Provision of information to patients with melanoma

#### MAJOR OUTCOMES CONSIDERED

-   Incidence of melanoma

-   Sensitivity and specificity of diagnostic tests and techniques

-   Accuracy of staging tools/techniques

-   Pathological features (e.g., lesion size, thickness, ulceration)

-   Patient outcomes including:

    -   Morbidity and mortality

    -   Survival rate

    -   Recurrence rate and time

    -   Side effects of treatment

    -   Symptom relief

    -   Quality of life

-   Outcomes for women who are pregnant or using oral contraceptives or
    hormone replacement therapy

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Literature searches were initially conducted in Medline, Embase, Cinahl,
Cancerlit, and the Cochrane Library using the year range 1993 to 2001.
The literature search was updated with new material during the course of
the guideline development process. A final update literature search was
performed in March 2003. Key Web sites on the Internet were also used,
such as the National Guidelines Clearinghouse. The searches were
extended back to 1970 in areas where evidence was scarce. These searches
were supplemented by the reference lists of relevant papers and group
members\' own files. The Medline version of the main search strategies
can be found on the Scottish Intercollegiate Guidelines Network (SIGN)
website.

#### 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

**Levels of Evidence**

**1++**: High quality meta-analyses, systematic reviews of randomised
controlled trials (RCTs), or RCTs with a very low risk of bias

**1+**: Well-conducted meta-analyses, systematic reviews of RCTs, or
RCTs with a low risk of bias

**1-**: Meta-analyses, systematic reviews of RCTs, or RCTs with a high
risk of bias

**2++**: High quality systematic reviews of case control or cohort
studies; high quality case control or cohort studies with a very low
risk of confounding or bias and a high probability that the relationship
is causal

**2+**: Well conducted case control or cohort studies with a low risk of
confounding or bias and a moderate probability that the relationship is
causal

**2-**: Case control or cohort studies with a high risk of confounding
or bias and a significant risk that the relationship is not causal

**3**: Non-analytic studies, e.g. case reports, case series

**4**: Expert opinion

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

The Scottish Intercollegiate Guidelines Network (SIGN) carries out
comprehensive systematic reviews of the literature using customized
search strategies applied to a number of electronic databases and the
Internet. This is often an iterative process whereby the guideline
development group will carry out a search for existing guidelines and
systematic reviews in the first instance, and after the results of this
search have been evaluated, the questions driving the search may be
redefined and focused before proceeding to identify lower levels of
evidence.

Once papers have been selected as potential sources of evidence, the
methodology used in each study is assessed to ensure its validity. SIGN
has developed checklists to aid guideline developers to critically
evaluate the methodology of different types of study design. The result
of this assessment will affect the level of evidence allocated to the
paper, which in turn will influence the grade of recommendation it
supports.

Additional details can be found in the companion document titled \"An
Introduction to the SIGN Methodology for the Development of
Evidence-based Clinical Guidelines\" (Edinburgh \[UK\]: Scottish
Intercollegiate Guidelines Network. \[SIGN publication; no. 50\]).
Available from the [SIGN Web
site](http://www.sign.ac.uk/methodology/index.html).

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

The process for synthesizing the evidence base to form graded guideline
recommendations is illustrated in the companion document titled \"An
Introduction to the SIGN Methodology for the Development of
Evidence-based Clinical Guidelines.\" (Edinburgh \[UK\]: Scottish
Intercollegiate Guidelines Network. \[SIGN publication; no. 50\],
available from the [SIGN Web
site](http://www.sign.ac.uk/methodology/index.html).

Evidence tables should be compiled, summarising all the validated
studies identified from the systematic literature review relating to
each key question. These evidence tables form an important part of the
guideline development record and ensure that the basis of the guideline
development group\'s recommendations is transparent.

In order to address how the guideline developer was able to arrive at
their recommendations given the evidence they had to base them on, SIGN
has introduced the concept of considered judgement.

Under the heading of considered judgement, guideline development groups
are expected to summarise their view of the total body of evidence
covered by each evidence table. This summary view is expected to cover
the following aspects:

-   Quantity, quality, and consistency of evidence

-   Generalisability of study findings

-   Applicability to the target population of the guideline

-   Clinical impact (i.e., the extent of the impact on the target
    patient population, and the resources need to treat them.)

Guideline development groups are provided with a pro forma in which to
record the main points from their considered judgement. Once they have
considered these issues, the groups are asked to summarise their view of
the evidence and assign a level of evidence to it, before going on to
derive a graded recommendation.

The assignment of a level of evidence should involve all those on a
particular guideline development group or subgroup involved with
reviewing the evidence in relation to each specific question. The
allocation of the associated grade of recommendation should involve
participation of all members of the guideline development group. Where
the guideline development group is unable to agree a unanimous
recommendation, the difference of opinion should be formally recorded
and the reason for dissent noted.

The recommendation grading system is intended to place greater weight on
the quality of the evidence supporting each recommendation and to
emphasise that the body of evidence should be considered as a whole and
not rely on a single study to support each recommendation. It is also
intended to allow more weight to be given to recommendations supported
by good quality observational studies where randomised controlled trials
(RCTs) are not available for practical or ethical reasons. Through the
considered judgement process guideline developers are also able to
downgrade a recommendation where they think the evidence is not
generalisable, not directly applicable to the target population, or for
other reasons is perceived as being weaker than a simple evaluation of
the methodology would suggest.

On occasion, there is an important practical point that the guideline
developer may wish to emphasise but for which there is not, nor is their
likely to be, any research evidence. This will typically be where some
aspect of treatment is regarded as such sound clinical practice that
nobody is likely to question it. These are marked in the guideline as
\"good practice points.\" It must be emphasized that these are
[not]{.underline} an alternative to evidence-based recommendations and
should only be used where there is no alternative means of highlighting
the issue.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

The grade of recommendation relates to the strength of the evidence on
which the recommendation is based. It does not reflect the clinical
importance of the recommendation.

**A**: At least one meta-analysis, systematic review of randomised
controlled trials (RCTs), or RCT rated as 1++ and directly applicable to
the target population; *or*

A body of evidence consisting principally of studies rated as 1+,
directly applicable to the target population, and demonstrating overall
consistency of results

**B**: A body of evidence including studies rated as 2++, directly
applicable to the target population, and demonstrating overall
consistency of results; *or*

Extrapolated evidence from studies rated as 1++ or 1+

**C**: A body of evidence including studies rated as 2+, directly
applicable to the target population and demonstrating overall
consistency of results; *or*

Extrapolated evidence from studies rated as 2++

**D**: Evidence level 3 or 4; *or*

Extrapolated evidence from studies rated as 2+

#### COST ANALYSIS

**Screening for cutaneous melanomas**

A well conducted cost-effectiveness analysis using a hypothetical cohort
of 50-year-old Australians suggested that screening for melanoma by
primary care physicians may be relatively cost effective. Comparing an
organised programme of screening to the existing opportunistic regime,
the model predicted that the cost per life-year saved for men was
Aus\$6,853 to \$12,137 for five-yearly and two-yearly screening
respectively. The programme was less cost effective in women principally
due to lower mortality from melanoma. The cost effectiveness of
screening in high-risk populations has also been addressed in two
American studies. The findings suggested that such programmes were cost
effective compared to other screening programmes used in the USA. The
cost-effectiveness ratios were however sensitive to changes in the cost
of the screening test and the prevalence of disease and hence the
economic efficiency of screening high-risk individuals in Scotland may
differ. *No economics evidence was found which would support mass
screening programmes*.

**Sentinel lymph node biopsy (SLNB)**

The key interest here is how the information obtained from the SLNB
changes patient management, subsequent outcomes and associated costs.
Only one study was identified, a cost analysis of 73 patients in the USA
undergoing SLNB or an elective lymph node dissection (ELND). The results
indicate that significant cost savings could be made by using SLNB
rather than elective lymph node dissection. The study was non-randomised
and hence subject to potential bias in the distribution of cost drivers
between the groups, making the conclusion unreliable. Information on
final patient outcomes was also lacking, making it hard to be certain of
the cost effectiveness of the intervention, particularly when applied to
the UK setting.

**Adjuvant interferon therapy**

Five economic evaluations or cost studies relating to adjuvant
interferon therapy were reviewed. Three studies used the trial results
from the E1684 trial and hence investigated the cost effectiveness of
adjuvant high-dose interferon therapy versus observation alone. These
studies all found cost per life year gained and cost per QALY (Quality
Adjusted Life Years) figures that would be considered broadly acceptable
by current conventions. The UK meta-analysis and economic analysis
however found insufficient evidence of benefit and thus, given its
considerable incremental cost, concluded that it could not be
recommended for routine use in the UK. The remaining economic evaluation
was a French study examining the cost effectiveness and cost utility of
low-dose interferon in patients with surgical resection of American
Joint Committee on Cancer (AJCC) stage II melanoma versus observation
alone. The cost effectiveness ratios in this study represent reasonable
value for money. The majority of economic evaluations were based on the
E1684 trial, however, that had the most positive findings; therefore
cost effectiveness will tend to have been overstated. Further, if no
significant difference exists in overall survival (as was found in the
E1684 and French studies), the use of life years gained as an outcome is
not tenable (since obviously no life years have been gained) rendering
the cost-effectiveness results invalid. The robustness of the findings
of the economic evaluations must be questioned.

**Follow up of patients with stage I and II disease**

A German study used retrospective case note review to examine the
relative cost effectiveness of various tests used in the follow-up of
patients with stage I-III disease. The study did not assess the value of
surveillance *per se* or the cost effectiveness of various frequencies
of contact. The results indicated that at any stage of melanoma and
follow-up the most cost-effective test was physical examination and that
lymph node sonography was the best performing imaging procedure, albeit
less cost effective than physical examination. Similar conclusions were
reached in a French study of patients with stage I melanoma. Both
studies suffered from methodological weaknesses, but they tend to
support the recommendations made in section 7 of the original guideline
document.

#### METHOD OF GUIDELINE VALIDATION

External Peer Review\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The national open meeting is the main consultative phase of Scottish
Intercollegiate Guidelines Network (SIGN) guideline development, at
which the guideline development group presents its draft recommendations
for the first time. The national open meeting for this guideline was
held in March 2002 and was attended by all of the key specialties
relevant to the guideline. The draft guideline was available on the SIGN
website for a limited period at this stage to allow those unable to
attend the meeting to contribute to the development of the guideline.

The guideline was also reviewed in draft form by a panel of independent
expert referees, who were asked to comment primarily on the
comprehensiveness and accuracy of interpretation of the evidence base
supporting the recommendations in the guideline.

As a final quality control check, the guideline is reviewed by an
Editorial Group comprising the relevant specialty representatives on
SIGN Council to ensure that the specialist reviewers\' comments have
been addressed adequately and that any risk of bias in the guideline
development process as a whole has been minimised.

Each member of the guideline development group then approved the final
guideline for publication.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

*Note from the Scottish Intercollegiate Guidelines Network (SIGN) and
National Guideline Clearinghouse (NGC): In addition to these
evidence-based recommendations, the guideline development group also
identifies points of best clinical practice in the original guideline
document.*

The strength of recommendation grading (A-D) and level of evidence (1++,
1+, 1-, 2++, 2+, 2-, 3, 4) are defined at the end of the \"Major
Recommendations\" field.

**Prevention, Surveillance, and Genetics**

**D** - Brochures and leaflets should be used to deliver preventive
information on melanoma to the general public.

**Diagnosis and Prognostic Indicators**

**D** - Clinicians should be familiar with the 7 point or the ABCDE
checklist for assessing lesions (see Tables 3 and 4 in the original
guideline document).

**D** - Clinicians using hand held dermatoscopy should be appropriately
trained.

**D** - Health professionals should be encouraged to examine patients´
skin during other clinical examinations.

**D** - A suspected melanoma should be excised with a 2-mm margin and a
cuff of fat.

**C** - If complete excision cannot be performed as a primary procedure,
a full thickness incisional or punch biopsy of the most suspicious area
is advised.

**C** - A superficial shave biopsy is inappropriate for suspicious
pigmented lesions.

**D** - The macroscopic description of a suspected melanoma should:

-   state the biopsy type, whether excision, incision, or punch

-   describe and measure the biopsy (in mm)

-   state the size of the lesion in mm and describe the lesion in detail
    (shape, pattern of pigment distribution, presence or absence of a
    nodular component, and presence or absence of ulceration)

-   state the clearance of the lesion (in mm) from the nearest lateral
    margin and the deep margin.

**D** - Selection of tissue blocks:

-   the entire lesion should be submitted for histopathological
    examination

-   the lesion should be sectioned transversely at 3 mm intervals and
    the blocks loaded into labeled cassettes

-   cruciate blocks should not be selected (they limit the assessment of
    low power architectural features such as symmetry).

**Note**: a photograph of the macroscopic specimen may be of great
value, especially if the precise origins of labeled blocks are drawn
onto the photograph to permit exact orientation.

**B** - The histogenetic type should be included in the pathology
report.

**B** - The growth phase characteristics should be stated in the
pathology report of all melanomas except nodular melanomas which, by the
time of diagnosis, show only vertical growth phase characteristics.

**B** - An accurate (to within 0.1 mm) measurement of the Breslow
thickness should be included in the pathology report for any melanoma
that has an invasive component.

**B** - The Clark level of invasion should be provided when the lesion
has a Breslow thickness \<1 mm.

**B** - The presence or absence of histological evidence of epidermal
ulceration should be noted in the pathology report.

**C** - If late regression is apparent, it should be included in the
pathology report.

**B** - Identification of lymphatic space invasion and/or microscopic
satellites should be included in the pathology report.

**B** - If the likelihood of survival is calculated using the Cochran
model, the breadth of any epidermal ulcer should be measured by
micrometer and stated in the pathology report.

**Surgical Management and Staging**

**D** - In pTis (melanoma in situ) a surgical excision margin of 2 to 5
mm is recommended to achieve complete histological excision. (p =
pathological; T = tumour)

**B** - In pT1 (melanoma 0- to 1-mm thickness) a surgical excision
margin of 1 cm is recommended.

**B** - In pT2 (melanoma 1- to 2-mm thickness) a surgical excision
margin of 1 to 2 cm is recommended.

**B** - In pT3 (melanoma 2- to 4-mm thickness) a surgical excision
margin of 2 cm is recommended.

**D** - In pT4 (melanoma \>4-mm thickness) a surgical excision margin of
2 cm is recommended.

**D** - The microscopic clearance of the tumour from the nearest lateral
margin and from the deep margin should be stated (in mm) for all
excision biopsies.

**B** - Radical lymph node dissection requires complete and radical
removal of all draining lymph nodes to allow full pathological
examination.

**B** - Elective lymph node dissection should not be routinely performed
in patients with primary melanoma.

**B** -- Sentinel lymph node biopsy (SLNB) should be considered as a
staging technique in patients with a primary melanoma [\>]{.underline}1
mm thick or a primary melanoma \<1 mm thick of Clark level 4 *(see
section 3.8.5 of the original guideline document)*.

**Further Investigations and Non-surgical Staging**

**C** - Chest x-ray, ultrasound scanning, and computerised tomography
scanning are not indicated in the initial assessment of primary melanoma
unless indicated for investigation of clinical symptoms and signs.

**D** - Routine blood tests are not indicated in staging asymptomatic
melanoma patients.

**Adjuvant Treatment of Stage II and III Disease**

**D** - The routine use of adjuvant radiotherapy is not recommended for
patients who have had therapeutic lymph node dissections.

**A** - Adjuvant interferon should not be used for American Joint
Committee on Cancer (AJCC) stage II and III melanoma patients other than
in a trial setting.

**Patient Follow-Up in Stage I, II and III Disease**

**D** - Patients who have had melanoma in situ do not require follow-up.

**D** - Routine full blood counts, liver function tests, tumour markers,
chest x-rays, ultrasound scans, computed tomography, and lactate
dehydrogenase are not recommended as part of a follow-up schedule in the
asymptomatic patient.

**B** - Healthcare professionals and members of the public should be
aware of the risk factors for melanoma.

**C** - Individuals identified as being at higher risk should be

-   advised about appropriate methods of sun protection

-   educated about the diagnostic features of cutaneous melanoma

-   encouraged to perform self examination of the skin

**D** - Genetic testing in familial or sporadic melanoma is not
appropriate in a routine clinical setting and should only be undertaken
in the context of appropriate research studies.

**Management of Stage IV Disease**

**A** - Dacarbazine (DTIC) is the standard single agent of choice in
stage IV melanoma.

**A** - Multiple drug regimens including those with tamoxifen and
interferon alpha do not improve survival compared to single agent DTIC
and are not recommended outside of clinical trials.

**D** - Single dose radiotherapy of a least 8 Gy is an effective
treatment for bone metastases.

**D** - Patients with good performance status, favourable response to
corticosteroid treatment, and the absence of systemic disease and who
harbour favourable central nervous system (CNS) disease should be
considered for surgical resection of their CNS disease.

**D** - If surgery is not possible, whole brain radiotherapy combined
with corticosteroids may help palliate neurological symptoms.

**B** - Patients with advanced melanoma require a coordinated
multiprofessional approach with input from a specialist palliative care
team.

**D** - Patients with poorly controlled symptoms should be referred to
specialist palliative care at any point in the cancer journey.

**Information for Patients**

**C** - Patients should receive targeted information throughout their
journey of care.

**[Definitions]{.underline}**:

**Grades of Recommendation**

**A**: At least one meta-analysis, systematic review of randomised
controlled trials (RCTs), or RCT rated as 1++ and directly applicable to
the target population; *or*

A body of evidence consisting principally of studies rated as 1+,
directly applicable to the target population, and demonstrating overall
consistency of results

**B**: A body of evidence including studies rated as 2++, directly
applicable to the target population, and demonstrating overall
consistency of results; *or*

Extrapolated evidence from studies rated as 1++ or 1+

**C**: A body of evidence including studies rated as 2+, directly
applicable to the target population and demonstrating overall
consistency of results; *or*

Extrapolated evidence from studies rated as 2++

**D**: Evidence level 3 or 4; *or*

Extrapolated evidence from studies rated as 2+

**Levels of Evidence**

**1++**: High quality meta-analyses, systematic reviews of randomised
controlled trials (RCTs), or RCTs with a very low risk of bias

**1+**: Well-conducted meta-analyses, systematic reviews of RCTs, or
RCTs with a low risk of bias

**1-**: Meta-analyses, systematic reviews of RCTs, or RCTs with a high
risk of bias

**2++**: High quality systematic reviews of case control or cohort
studies; high quality case control or cohort studies with a very low
risk of confounding or bias and a high probability that the relationship
is causal

**2+**: Well conducted case control or cohort studies with a low risk of
confounding or bias and a moderate probability that the relationship is
causal

**2-**: Case control or cohort studies with a high risk of confounding
or bias and a significant risk that the relationship is not causal

**3**: Non-analytic studies, e.g. case reports, case series

**4**: Expert opinion

#### CLINICAL ALGORITHM(S)

An algorithm is provided in the original guideline document for the
management of patients with melanoma.

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

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

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   Improved prevention and early detection of melanoma

-   Improved response to treatment

-   Improved survival

-   Improved patient quality of life, including:

    -   Better symptom control

    -   Reduced number of inpatient hospital days

    -   Reduced overall costs

    -   Increased patient satisfaction with treatment and outcomes

#### POTENTIAL HARMS

Not stated

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   This guideline is not intended to be construed or to serve as a
    standard of medical care. Standards of care are determined on the
    basis of all clinical data available for an individual case and are
    subject to change as scientific knowledge and technology advance and
    patterns of care evolve. These parameters of practice should be
    considered guidelines only. Adherence to them will not ensure a
    successful outcome in every case, nor should they be construed as
    including all proper methods of care or excluding other acceptable
    methods of care aimed at the same results.

-   The ultimate judgement regarding a particular clinical procedure or
    treatment plan must be made by the doctor, following discussion of
    the options with the patient, in light of the diagnostic and
    treatment choices available. It is advised however that significant
    departures from the national guideline or any local guidelines
    derived from it should be fully documented in the patient´s case
    notes at the time the relevant decision is taken.

-   Clinical diagnosis of melanoma is difficult and the accuracy of
    diagnosis may vary according to a clinician´s level of experience,
    with reports of considerable variation in sensitivity from 50 to 86%
    and an inverse relationship between sensitivity and experience.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

**Managed Clinical Networks (MCN)**

For a definition of Managed Clinical Networks refer to the original
guideline document.

**Resources Implications**

-   It is hard to ascertain whether the implementation of this guideline
    can be met within existing resources. This is because the guideline
    contains both recommendations that may require new funds for
    implementation and recommendations that may halt certain existing
    practices, thereby freeing up resources. The net effect of this is
    hard to quantify and will depend on current standards, practices and
    resources in each Health Board area.

-   By recommending that all health professionals should be encouraged
    to examine patients for potential melanomas, there is likely to be a
    potential impact on all areas of clinical practice in the National
    Health System (NHS) Scotland. Resources for staff training and
    education may be required to implement this recommendation. Many of
    the recommendations made in section 2 of the original guideline
    document will have an impact on pathology departments. Similarly,
    the need for appropriate palliation services recommended in section
    8.4 of the guideline may require investment if adequate services are
    not already available.

-   Palliative care services provided by charitable organisations may
    experience resource effects through the implementation of the
    guideline. Such organisations may also be involved in the provision
    of patient/carer information and support groups.

-   The costs of appropriate primary preventative products recommended
    in the guideline (sunscreens, hats, and clothing) will result in
    costs to patients.

-   Implementation of the guideline is unlikely to affect other groups.

#### IMPLEMENTATION TOOLS

Clinical Algorithm\
Patient Resources\
Quick Reference Guides/Physician Guides

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness\
Staying Healthy

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Scottish Intercollegiate Guidelines Network (SIGN). Cutaneous melanoma.
A national clinical guideline. Edinburgh (Scotland): Scottish
Intercollegiate Guidelines Network (SIGN); 2003 Jul. 50 p. (SIGN
publication; no. 72). \[277 references\]

#### ADAPTATION

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

#### DATE RELEASED

2003 Jul

#### GUIDELINE DEVELOPER(S)

Scottish Intercollegiate Guidelines Network - National Government Agency
\[Non-U.S.\]

#### SOURCE(S) OF FUNDING

Scottish Executive Health Department

#### GUIDELINE COMMITTEE

Not stated

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Guideline Development Group*: Dr Valerie Doherty (*Chairman*),
Consultant Dermatologist, Royal Infirmary, Edinburgh; Mr Taimur Shoaib
(*Secretary*), Specialist Registrar in Plastic Surgery, Canniesburn
Hospital, Glasgow; Ms Moira Black, Health Visitor, Perth; Dr David
Brewster, Director of Cancer Registration in Scotland, Information and
Statistics Division, Edinburgh; Dr Graham Duncan, General Practitioner,
Kirkcaldy; Dr Alan T Evans, Consultant Histopathologist, Ninewells
Hospital, Dundee; Dr Marie Fallon, Senior Lecturer in Palliative
Medicine, Western General Hospital, Edinburgh; Mrs Carol Horne, Manager,
TakTent Cancer Support, Glasgow; Professor Rona MacKie, Consultant
Dermatologist, Glasgow University; Mrs Lesley Marley, Senior Health
Promotion Officer, National Health System (NHS) Tayside, Dundee; Mr Alan
J McKay, Consultant Vascular Surgeon, Gartnavel General Hospital,
Glasgow; Dr Kathryn McLaren, Senior Lecturer, Pathology, University of
Edinburgh; Dr Iain McLellan, General Practitioner, Kilmalcolm
Renfrewshire; Dr Nigel McMillan, Consultant Radiologist, Western
Infirmary, Glasgow; Mr Jack Miller, Consultant Surgeon, Dr Gray´s
Hospital, Elgin; Dr Marianne Nicolson, Consultant in Medical Oncology,
Aberdeen Royal Infirmary; Dr Jonathan Norris, Consultant Dermatologist,
Dumfries and Galloway Royal Infirmary; Dr Gerry Robertson, Consultant
Clinical Oncologist, Beatson Oncology Centre, Glasgow; Mr Duncan
Service, Information Services Officer, Scottish Intercollegiate
Guidelines Network (SIGN); Mrs Karen Smith, Specialist Nurse, Plastic
Surgery, Ninewells Hospital, Dundee; Mr David Soutar, Consultant Plastic
Surgeon, Canniesburn Hospital, Glasgow; Ms Joanne Topalian, Programme
Manager, SIGN

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

All members of the Scottish Intercollegiate Guidelines Network (SIGN)
guideline development groups are required to complete a declaration of
interests, both personal and non-personal. A personal interest involves
payment to the individual concerned (e.g., consultancies or other
fee-paid work commissioned by or shareholdings in the pharmaceutical
industry); a non-personal interest involves payment which benefits any
group, unit, or department for which the individual is responsible
(e.g., endowed fellowships or other pharmaceutical industry support).
Details of the declarations of interest of any guideline development
group member(s) are available from the Scottish Intercollegiate
Guidelines Network executive.

#### GUIDELINE STATUS

This is the current release of the guideline.

Any amendments to the guideline in the interim period will be noted on
[Scottish Intercollegiate Guidelines Network (SIGN) Web
site](http://www.sign.ac.uk/new.html).

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[Scottish Intercollegiate Guidelines Network (SIGN) Web
site](http://www.sign.ac.uk/pdf/sign72.pdf).

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   Quick reference guide: Cutaneous melanoma. A national clinical
    guideline. Scottish Intercollegiate Guidelines Network, 2003. 2 p.
    Available in Portable Document Format (PDF) from the [Scottish
    Intercollegiate Guidelines Network (SIGN) Web
    site](http://www.sign.ac.uk/pdf/qrg72.pdf).

-   SIGN 50: A guideline developer´s handbook. Edinburgh (Scotland):
    Scottish Intercollegiate Guidelines Network. (SIGN publication; no.
    50). Available from the [SIGN Web
    site](http://www.sign.ac.uk/methodology/index.html).

-   Appraising the quality of clinical guidelines. The SIGN guide to the
    AGREE (Appraisal of Guidelines Research & Evaluation) guideline
    appraisal instrument. Edinburgh (Scotland): Scottish Intercollegiate
    Guidelines Network, 2001. Available from the [SIGN Web
    site](http://www.sign.ac.uk/methodology/agreeguide/index.html).

#### PATIENT RESOURCES

The following is available:

-   Information for patients. In: Cutaneous melanoma. A national
    clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate
    Guidelines Network (SIGN); 2003 Jun. 50 p. (SIGN publication; no.
    72). Electronic copies: Available in Portable Document Format (PDF)
    from the [Scottish Intercollegiate Guidelines Network (SIGN) Web
    site](http://www.sign.ac.uk/pdf/sign72.pdf).

-   Advice to patients -- cutaneous melanoma. Edinburgh (Scotland):
    Scottish Intercollegiate Guidelines Network (SIGN); 2 p. Electronic
    copies: Available in Portable Document Format (PDF) from the [SIGN
    Web site](http://www.sign.ac.uk/pdf/pat72.pdf).

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 NGC summary was completed by ECRI on April 26, 2004. The
information was verified by the guideline developer on July 15, 2004.

#### COPYRIGHT STATEMENT

Scottish Intercollegiate Guidelines Network (SIGN) guidelines are
subject to copyright; however, SIGN encourages the downloading and use
of its guidelines for the purposes of implementation, education, and
audit.

Users wishing to use, reproduce, or republish SIGN material for
commercial purposes must seek prior approval for reproduction in any
medium. To do this, please contact <sara.twaddle@nhs.net>.

Additional copyright information is available on the [SIGN Web
site](http://www.sign.ac.uk/guidelines/published/copyright.html).

### DISCLAIMER

#### NGC DISCLAIMER

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

All guidelines summarized by NGC and hosted on our site are produced
under the auspices of medical specialty societies, relevant professional
associations, public or private organizations, other government
agencies, health care organizations or plans, and similar entities.

Guidelines represented on the NGC Web site are submitted by guideline
developers, and are screened solely to determine that they meet the NGC
Inclusion Criteria which may be found at
<http://www.guideline.gov/about/inclusion.aspx> .

NGC, AHRQ, and its contractor ECRI Institute make no warranties
concerning the content or clinical efficacy or effectiveness of the
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those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or
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Readers with questions regarding guideline content are directed to
contact the guideline developer.

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Date Modified: 11/3/2008