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

Camara 2009.

Study characteristics
Patient sampling Prospective pilot study
Patient characteristics and setting 17 women with vulval cancer stage I/II: 16 with SCC, 1 with melanoma; number of groins dissected was not reported. It is unclear whether any women with stage IA were included
Median age: 75 years (37 to 83)
Setting: a tertiary institution in Germany from February 2003 to March 2007
Index tests Tc‐99m and blue dye
Histological methods and ultrastaging not described.
Target condition and reference standard(s) TC: groin lymph node involvement
RS: complete IFL
Flow and timing Tc‐99m and blue dye injected intradermally at 4 sites around the tumour. Timing and other details were not reported
SND and RS were performed during the same operation
 Withdrawals, if any, were not described
Comparative  
Notes Brief report. Results were not reported per groin
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 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    
    Low 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