Klar 2011.
Study characteristics | |||
Patient sampling | Prospective; consecutive enrolment; 4 exclusions | ||
Patient characteristics and setting | 20 women with vulval SCC, FIGO stage IB; 29 groins; 3 unilateral and 13 bilateral LNDs Excluded women with no obvious nodes or women with other histology Median age: 66 years (36 to 88) Setting: tertiary institution in Germany; September 2007 to March 2010 |
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Index tests | Tc‐99m only Histological methods: ultrastaging with IHC staining was performed for SNs if standard section with H&E stain was negative; standard sections with H&E stains were performed for other nodes (RS) |
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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 | After GA, 0.3 ml of 10 MBq (4 x 2.5) Tc‐99m was injected intradermally at 4 sites around the tumour. Detected immediately thereafter by gamma probe. Dissection was continued if more 'hot' nodes were identified (> 10% of the 'hottest' SN). SND and RS were performed during the same operation 4 withdrawals described including 1 woman with vaginal melanoma and 3 women with obvious groin node metastases |
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Comparative | |||
Notes | This study evaluates the feasibility of a more convenient and less invasive way of administering the index test (Tc‐99m only). Midline defined as within 1 cm of the midline |
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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 | Low | ||
DOMAIN 2: Index Test Test group | |||
Had the test operator performed 10 or more procedures? | Yes | ||
Low | 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 | ||
Low |