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 |
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Index tests | Tc‐99m and blue dye Histological methods and ultrastaging not described. |
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Target condition and reference standard(s) | TC: groin lymph node involvement RS: complete IFL |
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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 |
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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 |