ARTICLE
Auteur(s) : Michel Dandurand1, Thomas
Petit2, Philippe Martel3, Bernard
Guillot4
1Service de Dermatologie, CHU de Nîmes, F30900
Nîmes
2Laboratoire d’Anatomie Pathologique, CHU Bichat, F
75018 Paris
3ANAES, 2 avenue du Stade de France, 93218 Saint Denis
La Plaine
4Service de Dermatologie, CHU de Montpellier, F 34295
Montpellier cedex 5
Introduction
Objective
There are many clinical and histological subtypes of basal cell
carcinoma (BCC), with many different treatment modalities i.e.
numerous situations for the physician to consider.The aims of these
guidelines are:
- – to classify BCC subtypes according to their prognosis
and to simplify BCC terminology,
- – to propose diagnostic tests and treatment modalities
suited to each situation.
Scope of the guidelines
These guidelines do not cover:
- – BCCs developing during genodermatosis and
immunosuppression
- – multiple BCC
- – BCC in children
- – primary prevention and screening.
Assessment method
The guidelines were produced using a three-step method (Annex II)
comprising:
- (i) a critical appraisal of the literature published
from Jan. 1993 to Dec. 2003
- (ii) discussions within a working group (3
meetings)
- (iii) comments by peer reviewers.
They were graded on the basis of the level of evidence of the
supporting studies (Annex 2). If no grade is given, they are based
on agreement among professionals within the working group after
taking into account the comments of peer reviewers.
There is a vast amount of published data on BCC but it provides
low levels of evidence. This is largely because of the wide variety
of tumours, diagnostic techniques, treatment modalities and
endpoints (and ways of calculating recurrence rates). Several
guidelines are therefore based on agreement among working group
members. They were keen to provide healthcare professionals with a
practical decision-making tool suited to most clinical situations,
while emphasising that guidelines can be adapted to specific
circumstances.
Clinical and histological subtypes of BCC
According to the working group, BCCs should be divided into 3
clinical and 4 histological subtypes (table 1( Table 1 )). This is a convenient classification for
routine use that is relevant to the management of the disease and
that should help communication between health professionals.
A combination of histological subtypes may be present, in which
case the subtype of the least favourable component is the one to be
adopted.
There was no agreement among working group members on how to
classify fibroepithelioma of Pinkus. Some authors consider this to
be a rare anatomical and clinical form of BCC.
Two specific histological forms have also been identified:
- – Metatypical BCC: This is defined as BCC which
includes squamous carcinomatous differentiation. Classifying this
lesion as a histological subtype of BCC or as a transitional form
with squamous cell carcinoma remains controversial
- – Mixed or composite carcinoma: This is defined
as a combination of a BCC with a squamous cell carcinoma, each
component being histologically well distinct.
Table 1 Recommended classification of clinical and
histological BCC subtypes
|
Clinical subtypesa
|
Histological subtypesb
|
|
Nodular
|
A smooth translucent, greyish papule or nodule, with
telangiectasia. It gradually grows to a variable size with a pearly
border. A centrifugal spread is described in some cases.
|
Presence in the dermis of one or more large and well-circumscribed
masses or lobules consisting of basaloid cells with peripheral
palisading of the nuclei. Retraction features are usually
present.
|
|
Superficial
|
A flat, red, well-circumscribed plaque, with very slow centrifugal
spread, sometimes covered with small scales or crusts. The
characteristic keratin pearls are usually invisible to the naked
eye. It may present immediately as multiple lesions. It develops
mainly in areas where the skin is covered.
|
Presence of a tumour nest attached to the epidermis and/or hair
follicles, consisting of basaloid cells with peripheral palisading
of the nuclei. Retraction features are usually present and separate
the tumour cells from the stroma. Usually there appear to be
multiple tumour foci, separated by areas of normal skin.
|
|
Infiltrating
|
|
To be used only for: - Trabecular pattern: presence of small,
poorly defined, intradermal or occasionally dermal-hypodermal
tumour foci. These have few cells, arranged in irregular islands or
networks. There is often no or little palisading of the peripheral
nuclei. Tumour proliferation infiltrates into the dermis, with
fluid margins. - Micronodular pattern: large number of small tumour
foci (no validated values for size) forming well-defined lobules.
There may be some palisading of peripheral nuclei.
|
|
Morpheaform
|
A hard, shiny depressed plaque with ill-defined margins, often
difficult to see if there is no ulceration. It looks like a white
scar. It grows slowly and centrifugally. The tumour margins are
very difficult to define. The lesion may be unrecognised for a long
time and may eventually be very extensive.
|
The tumour foci are thin strands, sometimes consisting of a single
cell layer. The tumour cells are poorly differentiated and there is
no peripheral palisading. The tumour infiltrates a very sclerotic
tumour stroma. Tumour elements normally occupy the whole height of
the dermis, sometimes extending to the hypodermis.
|
aThese 3 clinical subtypes may be pigmented and/or may
ulcerate.
bThere may be further histological features
concerning the epithelial and/or stromal component (see full
report).
Prognostic factors and prognosis groups
The objective criterion for assessing prognosis is risk of
recurrence. Risk of local invasion, and difficulty in treating the
lesion in the event of recurrence, should also be considered.
Recurrence rate is influenced by the clinical and histological
factors summarized in table 2( Table 2
).
Age, lesion duration and sex are not risk factors for recurrence
(level of evidence 3).
Data are inconclusive on whether the following are risk factors
for recurrence:
- – immunosuppression and previous radiotherapy
- – perineural spread and aspects of the stromal or
epithelial component other than those defining the subtypes cited
above.
For practical purposes, BCCs can be classified into 3 prognosis
groups (table 3( Table 3 )) according to
risk of recurrence and to risk, in case of recurrence, of local
invasion and of difficulty of treatment. These groups should be
used to decide on treatment options.
Table 2 Risk factors for recurrence
|
Clinical
|
Histological
|
|
Location (level of evidence 3)
|
- low risk area: trunk and limbs
|
Aggressive formsa i.e.:
|
|
- intermediate risk area: forehead, cheek, chin, scalp and neck
|
- morpheaform subtype
|
|
- infiltrating subtype
|
|
- high risk area: nose and periorificial areas on the head and
neck.
|
- metatypical form (level of evidence 3)
|
|
Size (largest tumour diameter) (level of evidence 3)
|
> 1 cm for high risk area > 2 cm for low or
intermediate risk area
|
|
|
Clinical aspect (level of evidence 3)
|
Ill-defined or morpheaform subtypes
|
|
|
Primary/Recurrent forms (level of evidence 3)
|
Recurrent form
|
|
aWhen several subtypes are associated, the global
prognosis depends on the component with the poorest prognosis.
Table 3 Prognosis groups
|
Poor prognosis
|
Good prognosis
|
Intermediate prognosis
|
|
- clinical forms: morpheaform or ill-defined
|
- superficial primary BCC
|
- superficial recurrent BCC
|
|
- Pinkus tumour
|
- nodular BCC
|
|
- histological forms: aggressive
|
- nodular primary BCC :
|
< 1 cm in high risk area
|
|
- recurrent forms (apart from superficial BCC)
|
< 1 cm in intermediate risk area
|
> 1 cm in intermediate risk area
|
|
- nodular BCC >1 cm in high risk zone
|
< 2 cm in low risk area
|
> 2 cm in low risk area
|
Available treatments
The main criterion for assessing treatment efficacy is recurrence
rate. Different calculation methods and durations of follow-up are
used to determine rates, making it difficult to analyse published
results. The life-table cumulative 5-year recurrence rate should be
used.
For primary BCCs, life-table cumulative 5-year recurrence rate
is approximately:
- – 1% with Mohs micrographic surgery (MMS) and classical
surgical excision with frozen section
- – 5-10% with classical surgical excision, radiotherapy
and cryosurgery
- – 7-13% for curettage and cautery.
For recurrent tumours, it is approximately:
- – 5% with MMS
- – 10-20% with classical excision and radiotherapy
- – 40% with curettage and cautery.
Surgery (excluding Mohs micrographic surgery)
Surgery is the treatment of choice to which other techniques should
be compared. It has a high cure rate particularly because margins
are controlled histologically. The criteria governing excision
should be based mainly on prognosis (see recommended lateral
excision margins in table 4( Table 4 )).
The recommended lateral excision margins according to prognosis
are given in table 4.
In all cases, the deep margins are located in subcutaneous fat
tissue. The margins should reach (and in case of non-invasion
spare) the fascia (forehead), the perichondrium (ear, nose), or the
periosteum (scalp). For superficial BCC they may be less deep.
– Frozen sections
During classic surgery, frozen sections may be taken. These
fragments, as well as the rest of the operative specimen, should be
examined postoperatively. Frozen sections should be kept for BCCs
with a poor or intermediate prognosis (see Section VI.2 on
Treatment). In contrast to Mohs surgery, they allow examination of
only a very small proportion of margins. They should therefore be
taken as meticulously as possible from zones at risk of invasion.
When relevant, these zones should be indicated by the surgeon.
– Two-stage surgery
Two-stage excision surgery is an alternative to frozen sections
as paraffin-embedded margins can be examined before closing. Tissue
morphology is better preserved but there are no published data
indicating that two-stage surgery is more effective than frozen
section. The efficacy of both methods depends on the technique used
to examine the surgical margins. As for frozen sections, the
histological examination should focus, as meticulously as possible,
on zones at risk of invasion. Two-stage excision is particularly
indicated if closure will require a graft or flap, which makes
surgical revision difficult if excision is incomplete.
Table 4 Recommended lateral margins for excision
|
Prognosis
|
Recommended margin
|
Comment
|
|
Good
|
3-4 mm (grade C)
|
Statistically speaking, with this margin, excision is incomplete in
< 5% of cases
|
|
Intermediate
|
At least 4 mm
|
|
|
Poor
|
From 5 mm for some well-circumscribed tumours to ≥10 mm
for certain recurrent BCCs and morpheaform BCCs
|
If these margins cannot be complied with for functional or cosmetic
reasons, use frozen section or 2-stage surgery to ensure that the
margin is clear
|
Mohs micrographic surgery (MMS)
MMS is the technique with the lowest reported recurrence rates,
particularly for the treatment of BCC with a poor prognosis (level
of evidence 3) and should be reserved for this indication.
Recurrence rates for alternative treatments of poor prognosis BCC
are little documented (surgery with frozen sections) or not
documented at all (two-stage surgery). Comparative trials are
needed.
MMS requires a specialist team and good coordination to allow
slides to be prepared and read during the surgical procedure.
Today, only a few centres in France offer MMS, while it is current
practice in countries such as the United States. The technique
needs to be thoroughly assessed so that its use can be developed in
France, if appropriate.
Radiotherapy
Radiotherapy gives good results in terms of local control of many
clinical and histological forms of BCC. It requires prior
histological confirmation of the diagnosis. It may use low energy
X-ray (which is particularly suitable for treating BCC),
brachytherapy, or high-energy radiotherapy (photons or electrons),
depending on the clinical presentation.
Radiotherapy is contraindicated or not recommended in the
following cases:
- – It is contraindicated in genetic syndromes
predisposing to skin cancers such as basal cell naevus syndrome and
xeroderma pigmentosum.
- – It is not recommended as first-line treatment if
excision surgery is possible.
- – It is not recommended:
- – in subjects aged under 60 years,
- – as treatment for morpheaform BCC,
- – on areas such as ears, hands, feet, legs or genital
organs.
Radiotherapy should be reserved for cases where surgery is not
possible (contraindication to surgery, surgical problems, patient’s
refusal). In these circumstances, the best indications are:
- – BCC with incomplete excision
- – recurrenct BCC
- – nodular BCC of the head and neck, under 2 cm
- – BCC with invasion of bone or cartilage.
Minimum safety margins of 5-10 mm should be applied to the
irradiated volume depending on tumour prognosis.
Cryosurgery
Cryosurgery gives satisfactory results in terms of recurrence when
performed under optimum conditions in rigorously selected patients
(level of evidence 3). Biopsy is required prior to treatment. It is
an alternative when surgery is not possible, for:
- – superficial BCC in a zone with low risk of
recurrence
- – well-defined nodular BCC smaller than 1 cm
irrespective of location.
There is a risk of delayed healing on the legs.
Curettage and cautery
Curettage and cautery is a blind technique requiring a definite
clinical diagnosis, histological confirmation on the material
removed and an experienced operator. Under these conditions and for
the right indications, its efficacy is acceptable (level of
evidence 3). It is not a recommended technique as other treatments
are available but it may be considered for an area with low risk of
recurrence in the case of small (< 2 cm) nodular BCC and
superficial BCC.
Laser
There is insufficient data to support the use of CO2
laser in the treatment of BCC.
Dynamic phototherapy
Dynamic phototherapy cannot be recommended for BCC treatment on the
basis of available data and because the photosensitising agent has
no marketing authorisation in France. Published data suggest that
superficial BCC may benefit from dynamic phototherapy (level of
evidence 2).
Drug treatments
No drug treatment can be recommended at present.
- – 5-fluorouracil has no marketing authorisation
in France for treatment of BCC. According to the working group, its
efficacy in BCC treatment cannot be assessed from published
data.
- – Imiquimod is not sufficiently documented and
has no marketing authorisation for BCC treatment. The data suggest
that superficial BCC may benefit from Imiquimod (level of evidence
2).
- – Interferon has many side-effects and limited
efficacy (level of evidence 3).
Diagnosis
Role of biopsy
A biopsy should always be done:
- – when the clinical diagnosis is not certain ;
- – when a non-surgical treatment is proposed ;
- – for all clinical forms with a poor
prognosis ;
- – when the surgical procedure requires major
reconstruction.
Immediate excision may be performed for clinically very probable
BCC with a good prognosis if recommended safety margins (3 or
4 mm) are complied with. The diagnosis must be confirmed
histologically after excision.
The biopsy may be incision or punch biopsy. It should be
sufficiently deep to include the reticular dermis to detect any
infiltrating pattern and define the histological subtype as
accurately as possible.
Examination of histological samples
Either biopsy fragments or excision specimens may be used for
pathological examination. The surgeon should specify the specimen’s
orientation and ideally provide a diagram. The specimen should be
sent fresh (if it can be delivered quickly) or fixed (formol is
recommended for excision specimens).
The excision specimen, the lesion (if possible), and the
narrowest safety margin should be measured. The lesion should be
described macroscopically, the location of the narrowest safety
margin should be specified, and the orientation of the specimen
indicated.
Pathology report
A standard pathology report should be used, containing at least the
information shown in ( figure 1 ).
Work up to detect disease spread
As metastases from BCC are unusual, systemic disease spread should
not be looked for routinely. Suspicion of deep or local or regional
invasion warrants imaging examinations such as radiography,
ultrasonography and, in particular, CT scan and MRI, depending on
the location and the underlying tissue invasion.
Treatment strategy
Treatment is decided on the basis of the tumour prognosis groups
defined in Section III.2. However, factors unrelated to the tumour
may also be considered. These are:
- – patient’s choice ;
- – likely cosmetic and functional outcome ;
- – general health and life expectancy ;
- – concomitant treatment and disease ;
- – availability of techniques ;
- – practioner’s competence.
Age alone should not be a reason for not treating properly a
BCC.
Primary BCC
Treatment strategy for primary BCC is given in table 5( Table 5 ). Restrictions on the use of each
technique must be considered. Second- and third-line treatments are
offered when first- and second-line treatments, respectively,
cannot be used (contraindication to the technique, practical
problems with treatment, patient’s refusal).
Table 5 Treatment strategy for primary BCC
|
Prognosis
|
First linea
|
Second linea
|
Third line
|
|
Good
|
Surgery (margin: 3-4 mm), no frozen section
|
Radiotherapy
|
Curettage and cautery
|
|
Cryosurgery
|
|
Poor
|
Surgery (margin: 5-10 mm or more)
|
Radiotherapy
|
Other techniques are contraindicated
|
|
2-stage surgery Surgery with frozen section
|
|
MMS whenever available
|
|
Intermediate
|
Surgery (margin: at least 4 mm), no frozen section.
|
Radiotherapy
|
|
|
If margin cannot be complied with, surgery with frozen section or
2-stage surgery
|
Cryosurgery
|
aTechniques are not listed in rank order of relevance.
Incomplete excision
The working group recommended that incomplete excision be followed
immediately by revision as the rate of recurrence is approximately
50% and the prognosis for recurrent BCC (table 6( Table 6 )) is poorer than for primary BCC. There
is, however, no evidence that this approach is superior to
surveillance and treatment of any recurrences. Surveillance
therefore remains an option for BCC subtypes with a good prognosis.
There are no published data to recommend excision margins for
revision surgery.
– Recurrent forms
The recommended treatment strategy for recurrent forms is given
in table 7( Table 7 ).
– Role of multidisciplinary consultation
Most cases of BCC do not justify a treatment decision being
taken by a multidisciplinary team because the overall prognosis is
good and simple surgical treatment is possible. However, BCC types
that are more difficult to manage (multiple risk factors, cases
requiring complex surgery, local or regional invasion) should be
discussed by a multidisciplinary team.
Table 6 Treatment strategy when excision is
incomplete
|
Prognosis
|
First line
|
Second lineb
|
|
Poor
|
Surgery with frozen section 2-stage surgery
|
Radiotherapy
|
|
MMS whenever available
|
|
Good or Intermediate
|
Surgery without frozen sectiona
|
Radiotherapy
|
aSurveillance is an acceptable option for BCC subtypes
with a good prognosis.
bOnly if surgery is not possible.
Table 7 Treatment strategy for recurrent forms
|
Recurrent forms
|
First line
|
Second line
|
Third line
|
|
All but superficial BCC
|
Surgery with frozen section
|
Radiotherapy
|
Curettage and cautery and cryosurgery are not recommended
|
|
2-stage surgery
|
|
MMS whenever available
|
|
Superficial BCC
|
Surgery with a 4 mm margin, no frozen section
|
Radiotherapy
|
Curettage and cautery and cryosurgery can be considered
|
Follow-up of patients with BCC
Clinical monitoring is recommended because of the risk of
recurrence of BCC and because of the increased risk of further BCCs
(33-70% at 3 years), squamous cell carcinoma (1-20% at 3 years) or
melanoma (incidence doubled) (grade C). The patient should undergo
a check-up at least once a year for at least 5 years, and ideally
for life. The frequency may be increased if there are risk factors
for recurrence. All the skin surface should be examined in order to
diagnose and treat small lesions as early as possible.
Annex 1 - Participants
Learned societies consulted
Association française des chirurgiens maxillo-faciaux
Collège national des généralistes enseignants
Société de formation thérapeutique du généraliste
Société française de chirurgie plastique, reconstructrice et
esthétique
Société française de dermatologie
Société française de gériatrie
Société française de médecine générale
Société française d’ORL et de chirurgie de la face et du cou
Société française de pathologie
Société française de radiothérapie oncologique
Steering committee
Dr. Elie Calitchi, radiotherapist, Saint-Cloud
Dr. Michel Dandurand, dermatologist, Nîmes
Dr. Patrice Dosquet, Anaes
Dr. Christophe Ferron, ENT specialist, Nantes
Professor Bernard Guillot, group chair, dermatologist,
Montpellier
Dr. Philippe Martel, Anaes
Dr. Thomas Petit, report author, pathologist, Paris
Professor Jean-Jacques Voigt, pathologist, Toulouse
Working group
Professor Bernard Guillot, dermatologist, Montpellier, chair
Dr. Michel Dandurand, dermatologist, Nîmes, draft report
author
Dr. Thomas Petit, pathologist, Paris, draft report author
Dr. Philippe Martel, Anaes, project leader, Saint-Denis La
Plaine
Dr. Elie Calitchi, oncologist, radiotherapist, Boulogne
Dr. Alain Dupuy, dermatologist, Paris
Dr. Nicolas Froment, pathologist, Metz
Dr. Alain Jourdain, ENT specialist, Laval
Professor Jean-Louis Grolleau, plastic, aesthetic and
reconstructive surgeon, Toulouse
Dr. Sylvie Meaume, dermatologist, geriatrician,
Ivry-sur-Seine
Dr. Patrice Plantin, dermatologist, Quimper
Dr. Alain-Marc Ragaine, general practitioner, Villepinte
Dr. Luc Rethers, pathologist, Orléans
Professor Thierry Schmitt, radiotherapist, Saint-Étienne
Dr. Jean-François Sei, dermatologist, Saint-Germain-en-Laye
Dr. Éric Sorrel-Dejerine, maxillofacial and plastic surgeon,
Paris
Dr. Jacques Wagner-Ballon, general practitioner,
Joué-lès-Tours
Dr. Janine Wechsler, pathologist, Créteil
Peer reviewers
Dr. Guy Amelineau, general practitioner, Le Fenouiller
Dr. Lucile Andrac-Meyer, pathologist, Marseille
Dr. Gérard Andreotti, general practitioner, La Crau
Dr. Marie-Françoise Avril, dermatologist, Villejuif
Dr. Christiane Bailly, pathologist, Lyon
Professor Nicole Basset-Seguin, dermatologist, Paris
Professor Claude Beauvillain de Montreuil, ENT specialist,
Nantes
Professor Jean-Pierre Bessede, ENT specialist, Limoges
Professor Jean-Marie Bonnetblanc, dermatologist, Limoges
Professor Isabelle Bourdel-Marchasson, geriatrician,
endocrinologist, Pessac
Professor Daniel Buchon, general practitioner, Bugeat
Dr. Patrick Bui, reconstructive plastic surgeon, Paris
Dr. Elie Calitchi, radiotherapist, Saint-Cloud
Dr. Philippe Courville, pathologist, Rouen
Professor Bernard Cribier, dermatologist, Strasbourg
Dr. Emmanuel Delay, plastic surgeon, Lyon
Dr. Pierre Demolis, cardiologist, pharmacologist, AFSSAPS
Dr. Rémi Dendale, oncologist, radiotherapist, Paris
Professor François Disant, ENT specialist, cervicofacial
surgeon, Lyon
Professor Brigitte Dreno, dermatologist, Nantes
Professor Jean-Bernard Dubois, radiotherapist, Montpellier
Professor Alain Ducasse, ophthalmologist, Reims
Dr. Marc Ebel, geriatrician, Strasbourg
Dr. Dominique Egasse, dermatologist, Paris
Dr. Daniel Eilstein, epidemiologist, Strasbourg
Dr. Nathalie Faucher, geriatrician, Paris
Dr. Christophe Ferron, ENT specialist, Nantes
Dr. Sylvie Fraitag-Spinner, pathologist, Paris
Professor Jean-Jacques Grob, dermatologist, Marseille
Dr. Marguerite Grossin, pathologist, Colombes
Dr. Patrick Guillot, dermatologist, Arès
Dr. Laurent Guyot, maxillofacial surgeon, Marseille
Dr. Sylvette Hoffstetter, radiotherapist, Vandœuvre
Dr. Jean-Pierre Jacquet, general practitioner,
Saint-Jean-d’Arvey
Dr. Michel Lallement, oncology surgeon, Nice
Professor Éric Lartigau, radiotherapist, Lille
Dr. Jacques Martel, dermatologist/ venereologist, Chambéry
Dr. Ludovic Martin, dermatologist, Orléans
Dr. Hélène Mathieu-Daude, epidemiologist, Montpellier
Professor Jean-Michel Mondie, maxillofacial surgeon,
Clermont-Ferrand
Professor Jean-Paul Monteil, ENT specialist, maxillofacial
surgeon, Paris
Dr. Christine Pauwels, dermatologist, pathologist,
Saint-Germain-en-Laye
Dr. Daniel Poli, dermatologist, Avignon
Professor Bernard Ricbourg, maxillofacial surgeon, plastic,
aesthetic and reconstructive surgeon, Besançon
Professor Philippe Saiag, dermatologist, Boulogne
Professor Pierre Seguin, plastic surgeon, maxillofacial surgeon,
Saint-Étienne
Dr. Frédéric Staroz, pathologist, Quimper
Professor Sylvie Testelin, maxillofacial surgeon, Amiens
Dr. Béatrice Vergier, pathologist, Pessac
Dr. Olivier Verola, pathologist, Paris
Professor Jean-Jacques Voigt, pathologist, Toulouse
Annex 2 - Assessment method
The Anaes method for producing these clinical practice guidelines
1 comprised the following steps:
Defining the scope of the guidelines (Steering
committee). Anaes invited representatives from learned
societies concerned by the topic to take part in a steering
committee whose job was to define the scope of the guidelines and
to define quality of professionals to take part in a working group
or act as peer reviewers.
Literature search (Documentation Department of Anaes):
See below
Drafting the guidelines (Working group). The Anaes
project manager formed a working group of 16 professionals from a
number of disciplines, working in public or private practice, from
all over the country. The chair of the working group coordinated
the production of the guidelines with the help of the project
manager whose job was to ensure conformity with the methodological
principles of guideline production. Two members of the working
group identified, selected, and analysed relevant studies (from a
literature search performed by the Anaes Documentation Department)
and wrote a draft report. This draft report was discussed by the
working group over 3 meetings and amended accordingly. Proposals
for future studies and action were made.
External validation (Peer reviewers). Peer reviewers were
appointed according to the same criteria as working group members.
They were consulted by post after the second working group meeting,
with regard to the readability, applicability and relevance of the
guidelines (scores from 1 to 9). The Anaes project manager
summarized their comments and submitted them to the working group
prior to the third meeting. Peer reviewers were asked to undersign
the final document.
Internal validation (Evaluation Section of the Anaes
Scientific Council). Two members of the Council acted as
referees reporting to the Council. The working group finalized the
guidelines with due regard to the Council’s suggestions.
Literature search and analysis (general procedure)
The scope of the literature search was defined by the steering
committee and the project manager. The search was carried out by
the Anaes Documentation Department and focused on searching:
- – medical and scientific databases over an appropriate
period, with special emphasis on retrieving clinical practice
guidelines, consensus conferences, articles on medical
decision-making, systematic reviews, meta-analyses and other
assessments already published nationally or internationally
(articles in French or English)
- – specific and/or financial/economic databases, if
necessary
- – all relevant websites (government agencies,
professional societies, etc.)
- – the grey literature (documents not identified through
the usual information distribution circuits)
- – legislative and regulatory texts
Further references were obtained from citations in the articles
retrieved above and from working group members’ and peer reviewers’
own reference sources. The search was updated until the project was
completed.
The articles selected were analysed according to the principles
of a critical appraisal of the literature, using a checklist, to
allocate a level of scientific evidence to each study. Whenever
possible, the working group based their guidelines on this review
of the literature. Guidelines were graded from A to C as shown in
table 8( Table 8 ) depending on the
level of the evidence of the supporting studies. If no grading is
given, they are based on agreement among professionals.
Table 8 Grading of guidelines
|
Level of published scientific evidence
|
Grade
|
|
Level 1
|
A: Established scientific evidence
|
- Randomised controlled trials of high power
- Meta-analyses of randomised controlled trials
|
|
Decision analyses based on properly conducted studies
|
|
Level 2
|
B: Presumption of scientific foundation
|
|
Randomised controlled trials of low power
|
|
Properly conducted non-randomised controlled trials
|
|
Cohort studies
|
|
Level 3
|
C: Low level of evidence
|
|
Case-control studies
|
|
Level 4
|
|
Comparative studies with major bias
|
|
Retrospective studies
|
|
Case series
|
Synopsis
|
Title
|
Management of basal cell carcinoma (BCC) in adults
|
|
Publication date
|
March 2004
|
|
Requested by
|
Société Française de Dermatologie
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Produced by
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Anaes - French National Agency for Accreditation and Evaluation in
Healthcare (Guidelines Department)
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Intended for
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Health professionals involved in the management of BCC in
adults
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Assessment method
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- Systematic review of the literature (with evidence levels) -
Discussion among members of an ad hoc working group - External
validation by peer reviewers (see Anaes guide “Recommandations pour
la pratique clinique - base méthodologique pour leur réalisation en
France - 1999” available at www.anaes.fr)
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Objectives
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(i) To classify BCC subtypes according to their prognosis and
simplify BCC terminology (ii) To propose diagnostic tests and
treatment modalities suited to each situation.
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Literature search
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Jan 1993 - Dec 2003 153 articles selected among 378 analysed
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Economic study
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See full report (annex 3) available at www.anaes.fr
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Anaes project leader(s)
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Dr. Philippe Martel (Department head: Dr. Patrice Dosquet)
(Literature search: Emmanuelle Blondet with the help of Laurence
Frigère (Department head: Rabia Bazi)); secretarial work: Elodie
Sallez.
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Authors of draft report
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Dr Michel Dandurand, dermatologist, Nîmes Dr Thomas Petit,
pathologist, Paris
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Collaborations and participants (annex 1)
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- Learned societies - Steering committee - Working group (Chair:
Professor Bernard Guillot, dermatologist, Montpellier) - Peer
reviewers
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Internal validation
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Anaes Scientific Council (Referees: Professor Maryse Gadreau,
Professor Muriel Rainfray) Validated in March 2004
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Other Anaes publications on the topic
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None
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1 Full details are given in “Recommandations
pour la pratique clinique – base méthodologique pour leur
réalisation en France – 1999” (Anaes).
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