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. 2014 Jun 27;2014(6):CD010409. doi: 10.1002/14651858.CD010409.pub2

Hauspy 2007.

Study characteristics
Patient sampling Prospective study; consecutive enrolment; 42 recruited; 1 exclusion
Patient characteristics and setting 41 women with vulval cancer (39 SCC, 2 melanomas) at clinical stages T1/2 (68 groins). It is unclear whether any stage IA lesions were included
11 women had lateralised lesions and 30 had midline or near midline lesions
No palpable nodes
Median age: 65 years (34 to 94)
Setting: a tertiary institution in Canada from April 2004 to September 2006
Index tests SN detection by Tc‐99m with or without blue dye
Histological methods: frozen section and ultrastaging was performed for SNs with H&E and IHC stains; standard sections with H&E stains were performed for other nodes (RS)
Target condition and reference standard(s) TC: groin lymph node involvement
RS: complete IFL
Flow and timing Tc‐99m (0.1 to 0.2 mCi) was injected intradermally 2 to 4 hours pre‐operatively in 2 to 4 sites around the primary lesion, with or without up to 4 ml blue dye injected intradermally at the start of surgery. The node was considered 'hot' if radioactivity was 5 x background activity
SND and RS were performed during the same operation
 1 withdrawal described
Comparative  
Notes At the beginning of the study, all women received both Tc‐99m and blue dye, but later on blue dye was only used if the initial Tc‐99m test failed to identify SNs. Thus, combined tests and Tc‐99m only tests were used in 30 and 11 women, respectively. We were unable to extract separate 2 x 2 data for the combined and single techniques
Participants were stratified by the proximity of the lesion to the midline (midline; ≤ 1 cm of midline; lateralised)
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    
    Low Unclear
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