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membership to serve on the expert panel. The objective was to assemble a multidisciplinary panel. It was
therefore essential to include professionals from relevant disciplines gyn aecological oncology, medical
oncology, pathology, radiation oncology, surgery so that their perspectives would contribute to the validity and
acceptability of the guidelines. The list of the development group is available in Appendix 1.
3.2 Identification of scientific evidence
To ensure that the statements made in this document are evidence based, the current literature was reviewed and
critically appraised. A systematic literature review of the studies published between January 1980 and September
2015 was carried out using the MEDLINE database. This search used indexing terms as follows: accuracy,
adverse effects, bilateral en bloc dissection, biopsy, chemotherapy primary, neoadjuvant, adjuvant),
chemoradiation primary, neoadjuvant, adjuvant), chemotherapeutic agents, detection rate, diagnosis, en bloc
dissection, exenteration anterior, posterior, total), follow -up, frozen sections, groin lymph node involvement,
groin node metastasis, histology, histological examination, imaging, inguinofemoral lymph node dissection,
laboratory testing, local excision, lymph node dissection, lymphadenectomy, inguinofemoral or deep, inguinal
or superficial, ipsilateral, pelvic, lympho -vascular invasion, margin, node dissection, operation, pathology,
pathology report, pelvic-lymph node dissection, perioperative care, physical examination, postoperative
complications, preoperative care, preoperative workup, quality of life, radiotherapy primary, neoadjuvant,
adjuvant), radiation primary, neoadjuvant, adjuvant), radical local excision, reconstructive surger y, sensibility,
sentinel lymph node assessment, sentinel lymph node biopsy, sentinel lymph node dissection, specificity,
staging, surgical management, surgical outcome, surgical procedures, surgical resection, surveillance, survival
rate, survival analysis, systemic treatment, targeted therapy, toxicity, treatment outcome, tumour margin, vulvar
cancer early and/or advanced stages, vulvectomy radical, simple, modified, hemi) .
The literature search was limited to publications in English. Priority was given to high-quality systematic
reviews, meta-analyses, and randomized controlled trials but lower levels of evidence were also evaluated. The
search strategy excluded editorials, letters, and in vitro studies. The reference list of each identified article was
reviewed for other potentially relevant papers. The bibliography was also to be supplemented by additional
references provided by the international development group.
Another bibliographic search was carried out to identify previous initiatives using a systematic literature search
in MEDLINE database no restriction in the search period, indexing terms: clinical practice guidelines, evidence-
based medicine, guidelines, methodology, recommendations, vulvar cancer and a bibliographic search using
selected websites see Appendix 2 . All retrieved articles have been methodologically and clinically appraised.
After the selection and critical appraisal of the articles, a summary of the scientific evidence has been developed.
3.3 Formulation of guidelines
During the first meeting December 4, 2015, the Development group developed guidelines for diagnosis and
referral, preoperative investigations, surgical management local treatment, groin treatment, reconstructive
surgery, sentinel lymph node procedure, radiat ion therapy, chemoradiation, systemic treatment, treatment of
recurrent disease vulvar recurrence, groin recurrence, distant metastases, and follow -up.
The guidelines were retained if they were supported by sufficient high level scientific evidence and/or when a
large consensus among experts was obtained. By default, a guideline is the clinical approach that is unanimously
recognized by the Development group as being the criterion-standard clinical approach. If an approach is judged
to be acceptable but is not unanimously recognized as a criterion-standard clinical approach, indication is given
that it is still subject to discussion and/or evaluation. In the absence of any clear scientific evidence, judgment
was based on the professional experience and consensus of the development group expert agreement). The
reliability and quality of the evidence given throughout this document has been graded following the SIGN
grading system see Appendix 3.
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