Merisio 2005.
| Study characteristics | |||
| Patient sampling | Prospective study. Sampling not described | ||
| Patient characteristics and setting | 20 women with vulval SCC, clinically T1/2; 32 groins. Unclear whether any women with stage IA were included Excluded if clinically suspicious groin nodes, T3‐4 lesions or prior chemo/radiotherapy 9 lateral and 11 had midline lesions; 2 excisional biopsies Mean age: 75 (49 to 92) Setting: 2 tertiary institutions in Italy; enrolment from May 1999 to May 2003 |
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| Index tests | Tc‐99m only Histological methods: ultrastaging performed. IHC staining done for SNs if H&E stains were negative |
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| Target condition and reference standard(s) | TC: groin lymph node involvement RS: complete IFL (8 had unilateral and 12 had bilateral LND) |
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| Flow and timing | 16 hours pre‐operatively, Tc‐99m (10 to 20 MBq) was injected as 4 x intradermal peritumoural injections and immediately followed by LSG Early and late scans done and the SN/s location marked on skin. Detected intra‐operatively by hand‐held gamma probe SND and RS were performed during the same operation Withdrawals, if any, were not described |
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| Comparative | |||
| Notes | Lesions were considered midline if within 2 cm of the midline. 1 woman with a lateral lesion had bilateral IFL | ||
| 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? | Yes | ||
| 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 | ||
| 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 | |||