Pelosi 2003.

Study characteristics
Patient Sampling	Country: Italy Study design: prospective study of patients with early stage endometrial cancer between February 2001 and April 2002 Inclusion criteria: written informed consent signed. Exclusion criteria: not reported.
Patient characteristics and setting	Number of patients: 16 Mean age (standard deviation (SD)): 63 +/‐ 9.4 years (range, 50‐83) Mean/median BMI: not provided Histopathological cell type: adenocarcinoma = 16 (100%). No further information given. Unclear if any restriction on subtype. 1988 FIGO stage: Ib = 16 (100%). Converted to 2009 stage IA = 16. Grade on hysterectomy specimen: not reported Lymphovascular space involvement: not reported Setting: single centre in Italy.
Index tests	Type of endometrial sampling: not reported Experience of operator: not reported Tracer used and amount: 0.4 mL of 99mTc‐labelled albumin colloidal particles + 4 mL of patent blue dye. Method and timing of application: the day before surgery, 37 MBq of 99mTc‐labelled albumin colloidal particles were injected into the cervix, at 3, 6, 9 and 12 o'clock. The injection depth was 0.5 ±1 cm. Immediately before the surgical procedure (0 ± 20 minutes), in order to visualise SLNs, 4 mL of PBV was injected into the cervixat 3, 6, 9 and 12 o'clock (1 mL for each injection site). The injection depth was 0. 5 ±1 cm. Method of detection (histopathological assessment, including ultrastaging): SLNs were positively identified if they were blue, had in vivo radioactive counts at least three‐fold above background radioactivity, or both. Lymph nodes were marked as sentinel or non‐sentinel. The status of the dissected SLNs was examined to identify micrometastases by sections at reduced intervals (mean lymph node sections=24). Lymph nodes were formalin fixed, paraffin embedded and evaluated with haematoxylin and eosin and cytokeratin antibody (AE1/3, monoclonal antibody,1:250;Boehringer Mannheim, Indianapolis, IN, USA). A negative control was used. All non‐SLNs were evaluated with standard haematoxylin and eosin‐stained sections.
Target condition and reference standard(s)	Type: 16 patients with early stage endometrial cancer, all of whom received systematic pelvic lymphadenectomy alone. All surgeries were performed by laparoscopy. Lymph node number and site: a total of 24 SLNs was detected in 15 patients: six monolateral and 18 bilateral. All detected SLNs were internal iliac lymph nodes.
Flow and timing	All patients received the index and reference standard within 1 month. The patients all received the same reference standard (no patients received para‐aortic lymphadenectomy). All patients were included in the analysis.
Comparative
Notes	Study results: a total of 24 SLNs were identified and removed. In patients with a positive scan, an average of 1.6 SLNs were visualised. In one patient, SLNs were not localised with any technique. The sensitivity and negative predictive value of lymphoscintigraphy were both 100%. At histological analysis, three of the 24 were positive for micrometastases, whereas the remaining 21 were negative. No other surgically dissected lymph nodes presented metastases. TP = 3; FP = 0; FN = 0; TN = 12; failed = 1. 2009 FIGO stage IA = 16; IB+ = 0. Unclear if any restriction on tumour type (therefore assumed both). Cervical injection; bilateral detection in 9 patients. Adverse reaction from index or reference test: not reported Operating time: not reported Other intraoperative complications: not reported Other postoperative complications: not reported
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
Could the selection of patients have introduced bias?		Unclear risk
Are there concerns that the included patients and setting do not match the review question?			Low concern
DOMAIN 2: Index Test (All tests)
Were the index test results interpreted without knowledge of the results of the reference standard?	Unclear
If a threshold was used, was it pre‐specified?	No
Could the conduct or interpretation of the index test have introduced bias?		Unclear risk
Are there concerns that the index test, its conduct, or interpretation differ from the review question?			Low concern
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
Could the reference standard, its conduct, or its interpretation have introduced bias?		Unclear risk
Are there concerns that the target condition as defined by the reference standard does not match the question?			Low concern
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
Could the patient flow have introduced bias?		Low risk