Basta 2005.
| Study characteristics | |||
| Patient sampling | Prospective study; sampling methods are unclear. This study also included women with endometrial and cervical cancer but data were reported separately | ||
| Patient characteristics and setting | 39 women with vulval cancer FIGO stage I/II were included; number of groins was not reported. Number of midline/lateral lesions and tumour size was not reported Median age not reported Setting: a teaching hospital in Poland; enrolment period not reported |
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| Index tests | Tc‐99m and blue dye Histological methods included standard sections stained with H&E and IHC stains |
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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 | A total of 2.5 mCi Tc‐99m was injected peritumourally 14 to 18 hours pre‐operatively. 2 hours later, LSG was done. Blue dye (2 to 4 ml) was injected intra‐operatively 20 to 30 minutes before mapping SND and IFL were performed during the same operation Withdrawals, if any, were not described |
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| Comparative | |||
| Notes | Limited details reported; no data per groin (requested 21 June 2013) | ||
| 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 | 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 | |||