Hauspy 2007.
Study characteristics | |||
Patient sampling | Prospective study; consecutive enrolment; 42 recruited; 1 exclusion | ||
Patient characteristics and setting | 41 women with vulval cancer (39 SCC, 2 melanomas) at clinical stages T1/2 (68 groins). It is unclear whether any stage IA lesions were included 11 women had lateralised lesions and 30 had midline or near midline lesions No palpable nodes Median age: 65 years (34 to 94) Setting: a tertiary institution in Canada from April 2004 to September 2006 |
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Index tests | SN detection by Tc‐99m with or without blue dye Histological methods: frozen section and ultrastaging was performed for SNs with H&E and IHC stains; 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 | Tc‐99m (0.1 to 0.2 mCi) was injected intradermally 2 to 4 hours pre‐operatively in 2 to 4 sites around the primary lesion, with or without up to 4 ml blue dye injected intradermally at the start of surgery. The node was considered 'hot' if radioactivity was 5 x background activity SND and RS were performed during the same operation 1 withdrawal described |
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Comparative | |||
Notes | At the beginning of the study, all women received both Tc‐99m and blue dye, but later on blue dye was only used if the initial Tc‐99m test failed to identify SNs. Thus, combined tests and Tc‐99m only tests were used in 30 and 11 women, respectively. We were unable to extract separate 2 x 2 data for the combined and single techniques Participants were stratified by the proximity of the lesion to the midline (midline; ≤ 1 cm of midline; lateralised) |
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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 | 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 | ||
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 | ||
Unclear |