Moore 2003a.

Study characteristics
Patient sampling	Prospective study; sampling methods not described. Appear to have recruited 23 women and excluded 2 due to palpable groin nodes at surgery
Patient characteristics and setting	21 women with biopsy‐proven vulval SCC > 1 mm deep; 31 groins. No patients had undergone incisional biopsy before enrolment Excluded women with clinically suspicious nodes. Location and other details of the tumours was not reported Median age: NR Setting: 2 tertiary care hospitals in USA; recruitment dates not stated
Index tests	Tc‐99m and blue dye Ultrastaging with H&E staining was performed for SNs. Standard sections for other non‐SN nodes
Target condition and reference standard(s)	TC: groin lymph node involvement RS: complete IFL
Flow and timing	A total of 2 mCi Tc‐99m in 1 ml was injected at 2 sites around the tumour 90 to 180 minutes prior to surgery. LSG was performed. Intra‐operatively, 3 ml blue dye was injected at the same 2 sites. Detected intra‐operatively by gamma probe and visually (blue nodes). LNs with increased activity (> 5% of the injection site) were also removed. Nodes with a count of at least 10% of the hottest SN were defined as 'hot' SND and IFL were performed during the same operation
Comparative
Notes	10 bilateral IFL and 11 unilateral procedures were performed 3 women were found to have unilateral, palpable groin nodes, therefore the investigators excluded these 3 groins from the SN assessment. Tc‐99m detected SNs in all 31 groins but blue dye only detected 19/31 groins (61%) and 3/9 metastatic groins Metastases were also present in the non‐sentinel nodes of 5/9 SN positive groins
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled?	Unclear
Was a case‐control design avoided?	Yes
Did the study avoid inappropriate exclusions?	Unclear
		Unclear	Low
DOMAIN 2: Index Test Test group
Had the test operator performed 10 or more procedures?	Unclear
		Unclear	Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition?	Yes
Were the reference standard results interpreted without knowledge of the results of the index tests?	Unclear
		Unclear	Low
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard?	Yes
Did all patients receive the same reference standard?	Yes
Were all patients included in the analysis?	Yes
Were other imaging tests performed prior to the index test to rule out groin lymph node metastases?	Unclear
		Unclear