Louis‐Sylvestre 2006.
Study characteristics | |||
Patient sampling | Prospective study; consecutive sampling | ||
Patient characteristics and setting | 38 women with operable vulval cancer; 64 groins; depth of invasion > 1 mm; histology not specified; 12 lateralised and 26 median lesions Excluded if prior excisional biopsy. Included 6 women with clinically suspicious nodes (N1) Median age: 66 years (34 to 90) Setting: a tertiary institution in France; enrolled between June 2002 and December 2005 |
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Index tests | Tc‐99m and blue dye Blue dye was optional and not used in 8 women Histological methods: ultrastaging was not done. IHC staining was performed on SNs if H&E stain was negative |
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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 | 1 day pre‐operatively, Tc‐99m was injected in 3 x intradermal peritumoural injections (30 MBq) and immediately followed by LSG. SN site/s were located with hand‐held gamma probe and marked on the skin. Blue dye was injected in the same way intra‐operatively SND and RS were performed during the same operation Withdrawals not described |
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Comparative | |||
Notes | Considered midline if within 1 cm of the midline This study incorporates the data for 17 women from an earlier publication (Louis‐Sylvestre 2005) Due to the high risk of bias from the inclusion of 6 women with obvious groin involvement, we excluded these women in our data extraction. This resulted in a groin detection rate of 39/52 (compared with the published rate of 47/64) and no false negatives. (The only false negative in this study occurred in a woman with obvious bilateral groin node involvement) |
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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 | High | ||
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? | Unclear | ||
Were other imaging tests performed prior to the index test to rule out groin lymph node metastases? | Unclear | ||
Unclear |