Revel 2010.

Study characteristics
Patient sampling	Design: non‐comparative; retrospective (Prosp. database NR) Country: France Data collection: Jan 2005 to Sep 2008 Inclusion criteria: clinically node negative HN MM qithpre‐SLNB PET‐CT Excluded if or > 1 month between PET‐CT and SLNB
Patient characteristics and setting	Presentation: primary (pre‐SLNB) Number patients: 22 Number primary lesions: 22 Number LNBs/metastases: 21 Stage of disease: stage I or II Mean age: 60 years; Range: 18 to 88 years Male: 16 (73%) Primary lesion site: scalp 5, 23%; cheek 3, 14%; cervical or neck 3, 14%; atrial region (ear, mastoid, temples) 6, 27%; palpebral or periorbital 4, 18%; frontal 1, 5% Breslow/Clark: 4.5 mm (0.26 to 10 mm) Ulceration: unknown
Index tests	PET‐CT: Machine: Biograph 2 (Siemens1 Germany) (2003 to 2007); Biograph 6 True V imager (Siemens1) (2007 onwards) Scan coverage: WB; vertex to the toes Contrast: NR CT parameters: Biograph 2: 130 kV, 80 mAs; Biograph 6: 130 kV, 4D Care Dose; Biograph 2: 5 mm Biograph 6: 4 mm FDG: 5.5 MBq/kg for Biograph 2; 4 MBq/kg for Biograph 6 True V; Flucis1, Schering, Cisbio International Breath hold: no breath hold instructions reported CT used for: appears to be used for attenuation correction; also describes anatomical localisation on fused images Reconstruction: iterative reconstruction algorithms using Osem 3D, with correction of scatter and attenuation Threshold: any hypermetabolic focus more intense than the surrounding background, including equivocal foci, was systematically compared with the corresponding anatomical structure on the coupled CT, after accuracy of registration on merged PET‐CT images was verified. An FN was considered present if a patient was SLN positive and PET‐CT for the same basin was negative, regardless of whether PET was positive for a different LNB # Number observers: 2 Qualification (experience): NR (NR) Diagnosis (single, consensus, etc.): consensus of 2 Info provided during test interpretation: clinical ‐ localisation of the initial tumor and standard clinical and radiological assessment were known during image interpretation; other tests ‐ standard radiological assessment ‐ known but blinded to review of PET alone
Target condition and reference standard(s)	Histology (SLNB); FU Histological detail (n, %): H&E; IHC (S100, HMB45, melanA antibodies) (22, 100%). Histopathologist: NR FNAC (n, %): N/A (N/A) Follow‐up (n, %): NR (22/22, 100%) FU schedule: NR FU duration: mean 17 months (range 1 to 44) Reference blinding: NR # Target condition Data: per pt Definition: nodal mets; Prevalence: 10/20 = 50% (excluding 2 SLNB failures (histo only reference standard)); 12/22 = 55% (including 2 SLNB failures (histo + FU reference standard))
Flow and timing	Index to histology interval: 12 days; PET undergone in month before surgery Index to FU interval: NR Exclusions: n = 2; 2 test fails (no SN detected; however data can be extracted excluding these)
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 PET‐CT
Were the index test results interpreted without knowledge of the results of the reference standard?	Unclear
If a threshold was used, was it pre‐specified?	Yes
Was the imaging test applied and interpreted in a clinically applicable manner?	No
Were thresholds or criteria for diagnosis reported in sufficient detail to allow replication?	No
Was the test interpreted by an experienced examiner?	Yes
		Unclear	High
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