Kunte 2009.

Study characteristics
Patient sampling	Design: non‐comparative; prospective Data collection: Dec 2002 to Mar 2003 Inclusion criteria: cutaneous MM SLNB candidates; reported as 'mainly' ≥ 1.0 mm BT or risk factors (ulceration or regression or Clark level IV and V)
Patient characteristics and setting	Presentation: primary (pre‐SLNB) Number patients: 25 Number primary lesions: 25 Number LNBs/metastases: 68 LNBs; 35 SLNs Stage of disease: NR Mean age: 54 years; Median age: NR; Range: NR Male: 15 (60%) Primary lesion site: limbs 14, 56%; head and neck 2, 8%; trunk 9, 36% Breslow/Clark: Breslow ≤ 1 mm 8, 32%; 1.01 to 2 mm 11, 44%; 2.01 to 4 mm 5, 20%; > 4.0 mm 1, 4% Ulceration: 6, 24% Other: regression 0, 0%
Index tests	US: B‐mode; linear transducer Machine: SSA‐340 A; Toshiba Medical Systems, Neuss, Germany Scan coverage: regional lymphatic basins Contrast: N/A FNAC: no Threshold: qualitative presence of morphological features (described) # Number observers: 2 Qualification (experience): dermatologists (experienced) Diagnosis (single, consensus, etc.): unclear Info provided during test interpretation: clinical ‐ unclear; may be same dermatologists as for clinical exam; other tests ‐ pre and post lymphoscintigraphy ultrasound
Target condition and reference standard(s)	Histology (SLNB) Histological detail (n, %): H&E (serial section); IHC (S‐100, HMB 45, NKiC3, Melan A). LNs with histologically proven tumour deposits were considered metastatic except when fewer than 4 isolated tumour cells were present. The metastatic deposit was documented for each SLN concerning location within the LN and size (micro‐metastasis and macro‐metastasis) (25, 100%). Histopathologist: NR FNAC (n, %): – (0) Follow‐up (n, %): – (0) FU schedule: N/A FU duration: N/A Reference blinding: NR # Target condition Data: per pt Definition: nodal mets; Prevalence: 6/25 = 24% (6/35 SLN; 17%)
Flow and timing	Index to histology interval: < 24 hours Index to FU interval: N/A Exclusions: n = NR; NR
Comparative
Notes
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled?	Yes
Was a case‐control design avoided?	Yes
Did the study avoid inappropriate exclusions?	Yes
Does the study report results for participants at the same point in the clinical pathway and who would be eligible for imaging in normal practice?	Yes
Did the study report data on a per patient rather than per lesion basis?	Yes
		Low	Low
DOMAIN 2: Index Test Ultrasound (pre‐SLNB)
Were the index test results interpreted without knowledge of the results of the reference standard?	Yes
If a threshold was used, was it pre‐specified?	Yes
Was the imaging test applied and interpreted in a clinically applicable manner?	Unclear
Were thresholds or criteria for diagnosis reported in sufficient detail to allow replication?	Yes
Was the test interpreted by an experienced examiner?	Unclear
		Low	Unclear
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
Were the reference standard results based on patient follow‐up interpreted without knowledge of the original imaging test result?
Does the study use the same definition of disease positive as the primary review question (i.e. any mets) OR is it possible to disaggregate or regroup data such that data matching the review question can be extracted?	Yes
Was histology or cytology interpretation carried out by an experienced histopathologist or by a dermatopathologist?	Unclear
		Low	Unclear
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
		Low