Goni 2011.
Study characteristics | |||
Patient sampling | Prospective study | ||
Patient characteristics and setting | 24 women with vulval cancer (22 SCC; 2 other), clinical stage I and II. Number of groins evaluated is unclear Excluded women with clinically suspicious groin nodes Mean age: 71 (43 to 85) Setting: a tertiary institution in Spain; enrolment from 2001 to 2011 |
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Index tests | Tc‐99m only Standard histological methods were used for SN assessment and IHC staining was performed 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 | Procedure: 24 hours pre‐operatively, Tc‐99m was injected and LSG performed (details not reported). Radioactivity was detected intra‐operatively by hand‐held gamma probe. SND and RS were performed during the same operation Withdrawals were not described Mean follow‐up was 23 months | ||
Comparative | |||
Notes | Conference abstract only The number of women with midline/lateralised tumours and who underwent bilateral or unilateral IFL is not stated Midline lesions were not defined |
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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? | Unclear | ||
Was a case‐control design avoided? | Yes | ||
Did the study avoid inappropriate exclusions? | Unclear | ||
Unclear | Low | ||
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 |